Nepexto - patient leaflet, side effects, dosage

- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What Nepexto is and what it is used for

• 2. What you need to know before you use Nepexto

• 3. How to use Nepexto

• 4. Possible side effects

• 5. How to store Nepexto

• 6. Contents of the pack and other information

• 7. Instructions for use

1. What Nepexto is and what it is used for

Nepexto contains the active substance etanercept.

Nepexto is a medicine that is made from two human proteins. It blocks the activity of another protein in the body that causes inflammation. This medicine works by reducing the inflammation associated with certain diseases.

In adults (aged 18 and over), Nepexto can be used for:

• moderate or severe rheumatoid arthritis (long-term autoimmune disorder that primarily affects joints);
• psoriatic arthritis (a type of inflammatory arthritis which can affect any joint in the body);
• severe axial spondyloarthritis (a type of chronic inflammatory arthritis involving the spine and/or sacroiliac joints) including ankylosing spondylitis (a type of arthritis that affects the spine);
• moderate or severe psoriasis (raised, red, scaly patches on the skin).

In each case Nepexto is used, usually when other widely used treatments have not worked well enough or are not suitable for you.

For rheumatoid arthritis , this medicine is usually used in combination with methotrexate, although it may also be used alone if treatment with methotrexate is unsuitable for you. Whether used alone or in combination with methotrexate, Nepexto can slow down the damage to your joints caused by the rheumatoid arthritis and improve your ability to do normal daily activities.

For psoriatic arthritis patients with multiple joint involvement, this medicine can improve your ability to do normal daily activities.

For patients with multiple symmetrical painful or swollen joints (e.g., hands, wrists and feet), this medicine can slow down the structural damage to those joints caused by the disease.

Nepexto is also prescribed for the treatment of the following diseases in children and adolescents.

• For the following types of juvenile idiopathic arthritis when treatment with methotrexate has not worked well enough or is not suitable for them:

• – Polyarthritis (rheumatoid factor positive or negative) and extended oligoarthritis in patients from the age of 2 years and weighing 62.5 kg or more

• – Psoriatic arthritis in patients from the age of 12 years and weighing 62.5 kg or more

• For enthesitis-related arthritis in patients from the age of 12 years and weighing 62.5 kg or more when other widely used treatments have not worked well enough or are not suitable for them
• Severe psoriasis in patients from the age of 6 years and weighing 62.5 kg or more who have had an inadequate response to (or are unable to take) phototherapies or other systemic therapies.

2. What you need to know before you use Nepexto

Do not use Nepexto

• if you or the child you are caring for, are allergic to etanercept or any of the other ingredients of Nepexto (listed in section 6). If you or the child experience allergic reactions such as chest tightness, wheezing, dizziness or rash, do not inject more Nepexto, and contact your doctor immediately.
• if you or the child have or are at risk of developing a serious blood infection called sepsis. If you are not sure, please contact your doctor;
• if you or the child have an infection of any kind. If you are not sure, please talk to your doctor.

Warnings and precautions

Talk to your doctor before using Nepexto.

• Allergic reactions: If you or the child experience allergic reactions such as chest tightness, wheezing, dizziness or rash, stop using this medicine, and contact your doctor immediately.
• Infections/surgery: If you or the child develop a new infection, or are about to have any major surgery, your doctor may wish to monitor the treatment with this medicine.
• Infections/di­abetes: Tell your doctor if you or the child have a history of recurrent infections or suffer from diabetes or other conditions that increase the risk of infection.
• Infections/mo­nitoring: Tell your doctor of any recent travel outside the European region. If you or the child develop symptoms of an infection such as fever, chills or cough, tell your doctor immediately. Your doctor may decide to continue to monitor you or the child for the presence of infections after you stop using Nepexto.
• Tuberculosis: As cases of tuberculosis have been reported in patients treated with Nepexto, your doctor will check for signs and symptoms of tuberculosis before starting treatment with this medicine. This may include a thorough medical history, a chest X-ray and a tuberculin test. The conduct of these tests should be recorded on the Patient Card. It is very important that you tell your doctor if you or the child have ever had tuberculosis or have been in close contact with someone who has had tuberculosis. If symptoms of tuberculosis (such as persistent cough, weight loss, listlessness, mild fever), or any other infection appear during or after therapy, tell your doctor immediately.
• Hepatitis B: Tell your doctor if you or the child have or have ever had hepatitis B. Your doctor should test for the presence of hepatitis B infection before you or the child begin treatment with this medicine. Treatment with Nepexto may result in reactivation of hepatitis B in patients who have previously been infected with the hepatitis B virus. If this occurs, you should stop using this medicine.
• Hepatitis C: Tell your doctor if you or the child have hepatitis C. Your doctor may wish to monitor the treatment with this medicine in case the infection worsens.
• Blood disorders: Tell your doctor immediately if you or the child have any signs or symptoms such as persistent fever, sore throat, bruising, bleeding or paleness. Such symptoms may point to the existence of potentially life-threatening blood disorders, which may require discontinuation of Nepexto.
• Nervous system and eye disorders: Tell your doctor if you or the child have multiple sclerosis, optic neuritis (inflammation of the nerves of the eyes) or transverse myelitis (inflammation of the spinal cord). Your doctor will determine if using this medicine is an appropriate treatment.
• Congestive heart failure: Tell your doctor if you or the child have a history of congestive heart failure (when your heart muscle doesn’t pump blood as well as it should), because this medicine needs to be used with caution under these circumstances.
• Cancer: Tell your doctor if you have or have ever had lymphoma (a type of blood cancer) or any other cancer before you use this medicine. Patients with severe rheumatoid arthritis, who have had the disease for a long time, may be at higher than average risk of developing lymphoma. Children and adults using this medicine may have an increased risk of developing lymphoma or another cancer. Some children and teenage patients who have received etanercept or other medicines that work the same way as etanercept have developed cancers, including unusual types, which sometimes resulted in death. Some patients receiving Nepexto have developed skin cancer. Tell your doctor if you or the child develop any change in the appearance of the skin or growths on the skin.
• Chickenpox: Tell your doctor if you or the child are exposed to chickenpox when using this

medicine. Your doctor will determine if preventive treatment for chickenpox is appropriate.

• Alcohol abuse: Do not use this medicine for the treatment of hepatitis related to alcohol abuse.

Tell your doctor if you or the child in your care have a history of alcohol abuse.

• Wegener’s gra­nulomatosis: this medicine is not recommended for the treatment of Wegener’s gra­nulomatosis (a rare inflammatory disease). Tell your doctor if you or the child in your care have Wegener’s gra­nulomatosis.
• Anti-diabetic medicines: Tell your doctor if you or the child have diabetes or are taking medicines to treat diabetes. Your doctor may decide if you or the child need less anti-diabetic medicine while using this medicine.

Children and adolescents

• Vaccinations: If possible, children should be up to date with all vaccinations before using

Nepexto. Some vaccines, such as oral polio vaccine, should not be given while using this medicine. Tell your doctor before you or the child receive any vaccines.

Nepexto should not be used in children and adolescents who weigh less than 62.5 kg.

Nepexto should not be used in children with polyarthritis or extended oligoarthritis below the age of 2 years, or in children with enthesitis-related arthritis or psoriatic arthritis below the age of 12 years, or in children with psoriasis below the age of 6 years.

Other medicines and Nepexto

Tell your doctor or pharmacist if you or the child are taking or have recently taken or might take any other medicines (including sulfasalazine), including those not prescribed by your doctor.

You or the child should not use Nepexto with medicines that contain the active substance anakinra or abatacept.

Pregnancy and breast-feeding

Nepexto should only be used during pregnancy if clearly needed. You should consult your doctor if you become pregnant, think you may be pregnant, or are planning to have a baby.

If you received Nepexto during pregnancy, your baby may have a higher risk of getting an infection. In addition, one study found more birth defects when the mother had received etanercept in pregnancy, compared with mothers who had not received this medicine or other similar medicines (TNF-antagonists), but there was no particular kind of birth defect reported. Another study found no increased risk of birth defects when the mother had received etanercept in pregnancy. Your doctor will help you to decide whether the benefits of treatment outweigh the potential risk to your baby. It is important that you tell the baby’s doctors and other healthcare professionals about the use of Nepexto during pregnancy before the baby receives any vaccine (for more information see section 2, “Vaccinations”).

Women using Nepexto should not breast-feed, since etanercept passes into human breast milk

Driving and using machines

The use of Nepexto is not expected to affect the ability to drive or use machines.

Nepexto contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per dose, that is to say, essentially ‘sodium-free’.

3. How to use Nepexto

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

If you feel that the effect of Nepexto is too strong or too weak, talk to your doctor or pharmacist.

Use in adults

Rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis including ankylosing spondylitis The usual dose is 25 mg given twice a week or 50 mg once a week as an injection under the skin. However, your doctor may determine an alternative frequency at which to inject Nepexto.

Plaque psoriasis

The usual dose is 25 mg twice a week or 50 mg once a week.

Alternatively, 50 mg may be given twice a week for up to 12 weeks, followed by 25 mg twice a week or 50 mg once a week.

Your doctor will decide how long you should use Nepexto and whether retreatment is needed based on your response. If Nepexto has no effect on your condition after 12 weeks, your doctor may tell you to stop using this medicine.

Use in children and adolescents

Dose and frequency of dosing for the child or adolescent will depend on body weight and disease. Your doctor will determine the correct dose for the child and will prescribe an appropriate strength of etanercept.

Nepexto should not be used in children and adolescents who weigh less than 62.5 kg.

Other etanercept medicines with appropriate pharmaceutical forms for children are available.

For polyarthritis or extended oligoarthritis in patients from the age of 2 years, or enthesitis-related arthritis or psoriatic arthritis in patients from the age of 12 years, the usual dose is 0.4 mg of etanercept per kg bodyweight (up to a maximum of 25 mg) given twice a week or 0.8 mg of etanercept per kg of bodyweight (up to a maximum of 50 mg) given once a week.

For psoriasis in patients from the age of 6 years, the usual dose is 0.8 mg of etanercept per kg of bodyweight (up to a maximum of 50 mg) and should be given once weekly. If Nepexto has no effect on the child’s condition after 12 weeks, your doctor may tell you to stop using this medicine.

Method and route of administration

Nepexto is administered by an injection under the skin (by subcutaneous use).

Detailed instructions on how to prepare and inject Nepexto are provided in section 7, “Instructions for Use”.

Do not mix the solution with any other medicine.

To help you remember, it may be helpful to write in a diary which day(s) of the week Nepexto should be used.

If you use more Nepexto than you should

If you have used more Nepexto than you should (either by injecting too much on a single occasion or by using it too frequently), talk to a doctor or pharmacist immediately. Always have the outer carton of the medicine with you, even if it is empty.

If you forget to inject Nepexto

If you forget a dose, inject it as soon as you remember, unless the next scheduled dose is the next day; in which case skip the missed dose. Then continue to inject the medicine on the usual day(s). If you do not remember until the day that the next injection is due, do not use a double dose (two doses on the same day) to make up for a forgotten dose.

If you stop using Nepexto

Your symptoms may return upon discontinuation.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Allergic reactions

If any of the following happen, do not inject more Nepexto. Tell your doctor immediately or go to the casualty department at your nearest hospital.

• Trouble swallowing or breathing
• Swelling of the face, throat, hands, or feet
• Feeling nervous or anxious, throbbing sensations, sudden reddening of the skin and/or a warm feeling
• Severe rash, itching, or hives (elevated patches of red or pale skin that often itch)

Serious allergic reactions are rare. However, any of the above symptoms may indicate an allergic reaction to this medicine, so you should seek immediate medical attention.

Serious side effects

If you notice any of the following, you or the child may need urgent medical attention.

• Signs of serious infections, such as high fever that may be accompanied by cough, shortness of breath, chills, weakness, or a hot, red, tender, sore area on the skin or joints;
• Signs of blood disorders, such as bleeding, bruising, or paleness;
• Signs of nerve disorders, such as numbness or tingling, changes in vision, eye pain, or onset of

weakness in an arm or leg;

• Signs of heart failure or worsening heart failure, such as fatigue or shortness of breath with activity, swelling in the ankles, a feeling of fullness in the neck or abdomen, night-time shortness of breath or coughing, bluish colour of the nails or the lips;
• Signs of cancers: Cancers may affect any part of the body including the skin and blood, and

possible signs will depend on the type and location of the cancer. These signs may include weight loss, fever, swelling (with or without pain), persistent cough, presence of lumps or growths on the skin;

• Signs of autoimmune reactions (where antibodies are made that may harm normal tissues in the body) such as pain, itching, weakness, and abnormal breathing, thinking, sensation, or vision;
• Signs of lupus or lupus-like syndrome, such as weight changes, persistent rash, fever, joint or muscle pain, or fatigue;
• Signs of inflammation of the blood vessels such as pain, fever, redness or warmth of the skin, or itching.

These are rare or uncommon side effects but are serious conditions (some of which may rarely be fatal). If any of the above occurs, tell your doctor immediately, or visit the casualty department at your nearest hospital.

The known side effects of etanercept include the following on groups of decreasing frequency:

• Very common (may affect more than 1 in 10 people):

Infections (including colds, sinusitis, bronchitis, urinary tract infections and skin infections); injection site reactions (including bleeding, bruising, redness, itching, pain, and swelling) (these do not occur as often after the first month of treatment, some patients have developed a reaction at an injection site that was recently used); and headache.

• Common (may affect up to 1 in 10 people):

Allergic reactions; fever; itching; antibodies directed against normal tissue (autoantibody formation).

• Uncommon (may affect up to 1 in 100 people):

Serious infections (including pneumonia, deep skin infections, joint infections, blood infection, and infections at various sites); worsening of congestive heart failure; low red blood cell count, low white blood cell count, low neutrophil (a type of white blood cell) count; low blood platelet count; skin cancer (excluding melanoma); localised swelling of the skin (angioedema); hives (elevated patches of red or pale skin that often itch); eye inflammation; psoriasis (new or worsening); inflammation of the blood vessels affecting multiple organs; elevated liver blood tests (in patients also receiving methotrexate treatment, the frequency of elevated liver blood tests is common), abdominal cramps and pain, diarrhoea, weight loss or blood in the stool (signs of bowel problems).

• Rare (may affect up to 1 in 1,000 people):

Serious allergic reactions (including severe localised swelling of the skin and wheezing); lymphoma (a type of blood cancer); leukaemia (cancer affecting the blood and bone marrow); melanoma (a type of skin cancer); combined low platelet, red, and white blood cell count; nervous system disorders (with severe muscle weakness and signs and symptoms similar to those of multiple sclerosis or inflammation of the nerves of the eyes or spinal cord); tuberculosis; new onset congestive heart failure; seizures; lupus or lupus-like syndrome (symptoms may include persistent rash, fever, joint pain, and tiredness); skin rash, which may lead to severe blistering and peeling of the skin; lichenoid reactions (itchy reddish-purple skin rash and/or threadlike white-grey lines on mucous membranes); inflammation of the liver caused by the body's own immune system (autoimmune hepatitis; in patients also receiving methotrexate treatment, the frequency is uncommon); immune disorder that can affect the lungs, skin and lymph nodes (sarcoidosis); inflammation or scarring of the lungs (in patients also receiving methotrexate treatment, the frequency of inflammation or scarring of the lungs is uncommon).

• Very rare (may affect up to 1 in 10,000 people):

Failure of the bone marrow to produce crucial blood cells.

• Not known (frequency cannot be estimated from available data):

Merkel cell carcinoma (a type of skin cancer); Kaposi’s sarcoma (a rare cancer related to infection with human herpes virus 8. Kaposi’s sarcoma most commonly appears as purple lesions on the skin); excessive activation of white blood cells associated with inflammation (macrophage activation syndrome); recurrence of hepatitis B (a liver infection); worsening of a condition called dermatomyositis (muscle inflammation and weakness with an accompanying skin rash).

Additional side effects in children and adolescents

The side effects and their frequencies seen in children and adolescents are similar to those described above.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Nepexto

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and pre-filled pen after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2°C – 8°C). Do not freeze.

Keep the pre-filled pens in the outer carton in order to protect from light.

After taking a pre-filled pen from the refrigerator, wait approximately 30 minutes to allow the Nepexto solution in the pre-filled pen to reach room temperature. Do not warm in any other way. Use immediately.

Nepexto may be stored outside of the refrigerator at temperatures up to a maximum of 25°C for a single period of up to four weeks; after which, it should not be refrigerated again. Nepexto should be discarded if not used within four weeks after removal from the refrigerator. It is recommended that you record the date that Nepexto is removed from the refrigerator and the date after which Nepexto should be discarded (no more than 4 weeks following the removal from the refrigerator).

Inspect the solution in the pen. It should be clear or opalescent, colourless or yellow, and may contain small white or almost transparent particles of protein. This appearance is normal for Nepexto. Do not use the solution if it is discoloured, cloudy, or if particles other than those described above are present. If you are concerned with the appearance of the solution, then contact your pharmacist for assistance.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Nepexto contains

• – The active substance is etanercept. Each pre-filled pen contains 50 mg of etanercept.

• – The other ingredients are sodium citrate, sodium dihydrogen phosphate dihydrate, glycine,

sucrose, sodium chloride and water for injections.

What Nepexto looks like and contents of the pack

Nepexto is supplied as a pre-filled pen containing a clear to opalescent, colourless yellow solution for injection.

Nepexto is available in packs containing 4 or 12 pre-filled pens. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Mylan IRE Healthcare Limited

Unit 35/36 Grange Parade

Baldoyle Industrial Estate

Dublin 13

Ireland

Manufacturer

McDermott Laboratories Ltd T/A Mylan Dublin Biologics

Newenham Court

Northern Cross

Malahide Road

Dublin 17

Ireland

Mylan Germany GmbH

Zweigniederlassung Bad Homburg v. d. Hoehe, Benzstrasse 1

Bad Homburg v. d. Hoehe

Hessen, 61352

Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgie/Belgiqu­e/Belgien

Mylan EPD bvba/sprl

Tel/Tel: + 32 (0)2 658 61 00

Efc^rapufl MaňnaH EOOfl Ten: +359 2 44 55 400	Luxembourg/Lu­xemburg Mylan EPD bvba/sprl Tél/Tel: + 32 (0)2 658 61 00 (Belgique/Belgien)
Česká republika Mylan Healthcare CZ s.r.o. Tel: + 420 222 004 400	Magyarország Mylan EPD Kft Tel: + 36 1 465 2100
Danmark Viatris ApS Tlf: + 45 28 11 69 32	Malta V.J. Salomone Pharma Ltd Tel: + 356 21 22 01 74
Deutschland Mylan Healthcare GmbH Tel: +49 800 0700 800	Nederland Mylan Healthcare B.V. Tel: +31 (0)20 426 3300
Eesti BGP Products Switzerland GmbH Eesti filiaal Tel: + 372 6363 052	Norge Mylan Healthcare Norge AS Tel: + 47 66 75 33 00
EXÁáóa BGP nPOÏONTA M.E.n.E. TnX.: +30 210 9891 777	Österreich Mylan Österreich GmbH Tel: +43 1 86390
España Mylan Pharmaceuticals, S.L Tel: + 34 900 102 712	Polska Mylan Healthcare Sp. z.o.o. Tel: + 48 22 546 64 00
France Mylan Medical SAS Tel: +33 1 56 64 10 70	Portugal Mylan, Lda. Tel: + 351 21 412 72 56
Hrvatska Mylan Hrvatska d.o.o. Tel: +385 1 23 50 599	Romania BGP Products SRL Tel: + 40 372 579 000
Ireland Mylan Ireland Limited Tel: + 353 8711600	Slovenija Mylan Healthcare d.o.o. Tel: + 386 1 23 63 180
Ísland Icepharma hf Símí: +354 540 8000	Slovenská republika Mylan s.r.o. Tel: +421 2 32 199 100
Italia Mylan Italia S.r.l. Tel: + 39 02 612 46921	Suomi/Finland Mylan Finland Oy Puh/Tel: +358 20 720 9555
Kùnpoç Varnavas Hadjipanayis Ltd Tql: + 357 22207700	Sverige Mylan AB Tel: + 46 855 522 750
Latvija Mylan Healthcare SIA Tel: +371 676 055 80	United Kingdom (Northern Ireland) Mylan IRE Healthcare Limited Tel: +353 18711600

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site:.

7. Instructions for use

Read the Instructions for use before you start using Nepexto and each time you get a refill of your prescription. There may be new information.

Do not try to give yourself the injection unless your doctor or nurse has shown you how to give the injection.

Not included in pack:

• Alcohol swab
• Gauze pad and plaster
• Sharps disposal container

Device Parts

A. Prepare for injection

Find a well-lit, clean flat surface and gather all the equipment you need.

• 1. Take the Nepexto carton containing the pre-filled pens out of the refrigerator and place it on a flat work surface. Remove one pre-filled pen and place iton your work surface. Do not shake the pre-filled pen. Place the carton containing any remaining pre-filled pen back into the refrigerator. Never recap the needle.

Please see section 5 for instructions on how to store Nepexto. If you have any questions about storage, contact your doctor, nurse or pharmacist for further instructions.

• Do not use the pre-filled pen past the expiry date.
• Do not use the pre-filled pen if it has been dropped onto a hard surface (components inside the

pre-filled pen may be broken).

• Do not use the pre-filled pen if the needle cap is missing or not securely attached.

• 2. Inspect the solution:

Look at the medicine through the viewing window.

• The medicine should be clear or opalescent, colourless or yellow, and may contain small white or almost transparent particles of protein.
• Do not use the solution if it is discoloured, cloudy, or if particles other than those described above are present.

• 3. Allow the medicine to reach room temperature:

Remove one pre-filled pen from the carton that is stored in the refrigerator and leave at room temperature for at least 30 minutes before injecting.

This is important to make the medicine easier and more comfortable to inject.

• Do not remove the needle cap until you are ready to inject.
• Do not use heat sources, such as a microwave or hot water, to warm Nepexto.

• 4. Choose an injection site:

The pre-filled pen is for a subcutaneous injection.

It should be injected into the thigh, abdomen, or back of the upper arm (see image on the right).

Rotate the site for each injection.

If you are injecting into the abdomen, choose a site that is at least 5 cm away from the belly button.

• Do not inject into areas that are red, hard, bruised, or tender.

Do not inject into scars or stretch marks.

If you have psoriasis, do not inject into any raised, thick, red, or scaly skin patches, or lesions.

• B. Injection steps

Step 1:

Wash your hands with soap and water.

Step 2:

Wipe the skin at the injection site with an alcohol swab.

See ‘4. Choose an injection site’ for guidance with choosing an injection site.

• Do not touch this area again before giving the injection.

Step 3:

Pull the needle cap straight off and dispose of it in the bin or sharps container.

• Do not twist or bend the needle cap while removing it, as this may damage the needle.
• Never recap the needle.

Step 4:

Gently stretch the skin at the cleaned injection site.

Position the pre-filled pen approximately 90 degrees to the skin.

• Do not pinch the skin.
• Stretching the skin creates a firm surface.

Step 5:

Firmly press the pre-filled pen down into the site to start the injection.

The device will click when the injection begins.

Continue to hold the pre-filled pen firmly pressed into the site.

The device will click a second time.

Step 6:

After the second click, count slowly to 15 to make sure that the injection is complete.

• Do not release pressure against the injection site before the injection is complete.
• Do not move the pre-filled pen during the injection.

• C. Injection site care

If there is bleeding at the injection site, press a gauze pad over the injection site.

• Do not rub the injection site.

If needed, cover the injection site with a plaster.

If you have any questions or require further information, please talk with your doctor, nurse or p harmacist.

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