Patient leaflet - Adcirca 2 mg/ml oral suspension
1. What ADCIRCA is and what it is used for
ADCIRCA contains the active substance tadalafil.
ADCIRCA is a treatment for pulmonary arterial hypertension in adults and in children aged 2 years and above. The oral suspension is intended for paediatric patients who are not able to swallow tablets and whose dose is 20 mg.
It belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors which work by helping the blood vessels around your lungs relax, improving the flow of blood into your lungs. The result of this is an improved ability to do physical activity.
2. What you need to know before you take ADCIRCA
Do not take ADCIRCA
- if you are allergic to tadalafil or any of the other ingredients (see section 6).
if you are taking any form of nitrates such as amyl nitrite, used in the treatment of chest pain.
ADCIRCA has been shown to increase the effects of these medicines. If you are taking any form of nitrate or are unsure tell your doctor.
- if you have ever had loss of vision – a condition described as “stroke of the eye” (non-arteritic anterior ischemic optic neuropathy - NAION).
- if you have had a heart attack in the last 3 months.
- if you have low blood pressure.
- if you are taking riociguat. This medicine is used to treat pulmonary arterial hypertension (i.e., high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e., high blood pressure in the lungs secondary to blood clots). PDE5 inhibitors, such as ADCIRCA, have been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure tell your doctor.
Warnings and precautions
Talk to your doctor before taking ADCIRCA.
Before taking ADCIRCA, tell your doctor if you have:
- any heart problems other than your pulmonary hypertension
- problems with your blood pressure
- any hereditary eye disease
- an abnormality of red blood cells (sickle cell anaemia)
- cancer of the bone marrow (multiple myeloma)
- cancer of the blood cells (leukaemia)
- any deformation of your penis, or unwanted or persistent erections lasting more than 4 hours
- a serious liver problem
- a serious kidney problem.
If you experience sudden decrease or loss of vision or your vision is distorted, dimmed while you are taking ADCIRCA, stop taking ADCIRCA and contact your doctor immediately.
Decreased or sudden hearing loss has been noted in some patients taking tadalafil. Although it is not known if the event is directly related to tadalafil, if you experience decreased or sudden hearing loss, contact your doctor immediately.
Children and adolescents
ADCIRCA is not recommended for the treatment of pulmonary arterial hypertension in children under 2 years of age because it has not been studied in this age group.
Other medicines and ADCIRCA
Tell your doctor if you are taking, have recently taken or might take any other medicines. Do NOT take this oral suspension if you are already taking nitrates.
Some medicines may be affected by ADCIRCA or they may affect how well ADCIRCA will work. Tell your doctor or pharmacist if you are already taking:
- bosentan (another treatment for pulmonary arterial hypertension)
- nitrates (for chest pain)
- alpha blockers used to treat high blood pressure or prostate problems
- riociguat
- rifampicin (to treat bacterial infections)
- ketoconazole tablets (to treat fungal infections)
- ritonavir (for HIV treatment)
- tablets for erectile dysfunction (PDE5 inhibitors).
ADCIRCA with alcohol
Drinking alcohol may temporarily lower your blood pressure. If you have taken or are planning to take ADCIRCA, avoid excessive drinking (over 5 units of alcohol), since this may increase the risk of dizziness when standing up.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Do not take ADCIRCA when pregnant, unless it is strictly necessary and you have discussed this with your doctor.
Do not breast-feed while taking the oral suspension as it is not known if the medicine passes into human breast milk. Ask your doctor or pharmacist for advice before taking any medicine while pregnant or breast-feeding.
When dogs were treated there was reduced sperm development in the testes. A reduction in sperm was seen in some men. These effects are unlikely to lead to a lack of fertility.
Driving and using machines
Dizziness has been reported. Check carefully how you react to this medicine before driving or using any machinery.
ADCIRCA contains sodium benzoate (E211)
This medicine contains 2.1 mg sodium benzoate in each mL.
ADCIRCA contains sorbitol (E420)
This medicine contains 110.25 mg sorbitol in each mL. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine.
ADCIRCA contains propylene glycol (E1520)
This medicine contains 3.1 mg propylene glycol in each mL.
ADCIRCA contains sodium
This medicine contains less than 1 mmol sodium (23 mg)per 1 mL, that is to say essentially ‘sodium-free’.
3. How to take ADCIRCA
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
ADCIRCA oral suspension is supplied in a bottle. This is part of a pack which also includes a dosing device containing a 10 mL oral syringe marked in 1 mL increments and a press-in-bottle adaptor. Read the instructions for use booklet, which is included in the carton for instructions on how to use the adaptor and the syringe.
The recommended dose is 10mL of oral suspension once daily for children aged 2years and above and weighing less than 40kg.
If you have a mild or moderate liver or kidney problem, your doctor may prescribe a lower dose.
The oral suspension should be taken on an empty stomach at least 1 hour before or 2 hours after a meal.
If you take more ADCIRCA than you should
If you or anyone else takes more suspension than they should, tell your doctor or go to a hospital immediately, taking the medicine bottle with you. You may experience any of the side effects described in section 4.
If you forget to take ADCIRCA
Take your dose as soon as you remember if it is within 8 hours of when you should have taken your dose. Do NOT take a double dose to make up for the one that you have forgotten.
If you stop taking ADCIRCA
Do not stop taking your medicine, unless advised otherwise by your doctor.
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. These effects are normally mild to moderate in nature.
If you experience any of the following side effects stop using the medicine and seek medical help immediately:
- allergic reactions including skin rashes (frequency common).
- chest pain - do not use nitrates, but seek immediate medical assistance (frequency common).
- priapism, a prolonged and possibly painful erection after taking ADCIRCA (frequency uncommon). If you have such an erection, which lasts continuously for more than 4 hours you should contact a doctor immediately.
- sudden loss of vision (rarely reported), distorted, dimmed, blurred central vision or sudden decrease of vision (frequency not known).
The following side effects have been very commonly reported in patients taking ADCIRCA (may affect more than 1 in 10 people): headache, flushing, nasal and sinus congestion (blocked nose), nausea, indigestion (including abdominal pain or discomfort), muscle aches, back pain and pain in the extremity (including limb discomfort)
Other side effects have been reported:
Common (may affect up to 1 in 10 people)
- blurred vision, low blood pressure, nosebleed, vomiting, increased or abnormal uterine bleeding, swelling of the face, acid reflux, migraine, irregular heartbeat and fainting.
Uncommon (may affect up to 1 in 100 people)
- seizures, passing memory loss, hives, excessive sweating, penile bleeding, presence of blood in semen and/or urine, high blood pressure, fast heart rate, sudden cardiac death and ringing in the ears.
PDE5 inhibitors are also used for the treatment of erectile dysfunction in men. Some side effects have been rarely reported:
- Partial, temporary or permanent decrease or loss of vision in one or both eyes and serious allergic reaction which causes swelling of the face or throat. Sudden decrease or loss of hearing has also been reported.
Some side effects have been reported in men taking tadalafil for the treatment of erectile dysfunction. These events were not seen in clinical trials for pulmonary arterial hypertension and therefore frequency is unknown:
- swelling of the eyelids, eye pain, red eyes, heart attack and stroke.
Some additional rare side effects have been reported in men taking tadalafil that were not seen in clinical trials. These include:
- distorted, dimmed, blurred central vision or sudden decrease of vision (frequency not known).
Most but not all of those men reporting fast heart rate, irregular heartbeat, heart attack, stroke and sudden cardiac death had known heart problems before taking tadalafil. It is not possible to determine whether these events were related directly to tadalafil.
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 via the Yellow Card Scheme; website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store ADCIRCA
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 bottle after ‘EXP’. The expiry date refers to the last day of that month.
Do not use the medicine if the bottle has been open for more than 110 days. This medicine does not require any special storage conditions.
Store in the original package. Store the bottle upright.
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 ADCIRCA contains
The active substance is tadalafil. Each mL contains 2 mg of tadalafil.
The other ingredients are xanthan gum, microcrystalline cellulose, carmellose sodium, citric acid, sodium citrate, sodium benzoate (E211), silica (colloidal anhydrous), sorbitol (E420) (liquid crystallising), polysorbate 80, sucralose, simethicone emulsion (simethicone, methylcellulose, sorbic acid, purified water), artificial cherry flavour (contains propylene glycol (E1520) and water. See section 2 “ADCIRCA contains” for more information about sorbitol, sodium benzoate, propylene glycol and sodium.
What ADCIRCA looks like and contents of the pack
ADCIRCA 2 mg/mL is a white to practically white oral suspension.
ADCIRCA is packaged in a bottle containing 220 mL of oral suspension with a peelable seal and child-resistant closure, inside a carton. Each carton contains one bottle, a 10 mL graduated syringe with 1 mL graduations and a press-in-bottle adaptor.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Eli Lilly Nederland B.V., Orteliuslaan 1000, 3528 BD Utrecht, The Netherlands
Manufacturer: Lilly S.A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spain
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
United Kingdom
Eli Lilly and Company Limited
Tel: + 44-(0) 1256 315000
This leaflet was last revised in
INSTRUCTIONS FOR USE
ADCIRCA 2mg/mL oral suspension
tadalafil
Before you use ADCIRCA oral suspension, read and carefully follow all the step-by-step instructions.
This “Instructions for Use” contains information on how to use ADCIRCA oral suspension.
IMPORTANT INFORMATION YOU NEED TO KNOW BEFORE USING ADCIRCA ORAL SUSPENSION
The adaptor represents a CHOKING HAZARD – small parts. Do not attach the oral syringe to the adaptor until the adaptor is fully inserted into the bottle. It must be inserted completely into the bottle for safe use. To be used only under adult supervision.
Do not let your child take the medicine without your help.
Do not use if bottle, seal, adaptor, or oral syringe is damaged.
Do not use the medicine if the bottle has been open for more than 110 days. See the Disposal section to find out what to do with the medicine you don’t use.
Record date of first opening of bottle here: _________________________
Do not wash the oral syringe with soap or detergent. Please see steps 4b - 4c for cleaning instructions.
Do not put the oral syringe in the dishwasher. The syringe may not work as well as it should.
Use a new oral syringe after 30 days.
It is not recommended to mix the medicine with food or water. It may affect the taste or prevent the receiving full dose.
Give ADCIRCA oral suspension only using the oral syringe supplied with the medicine.
The medicine is white. Air gaps may be difficult to see in the oral syringe when preparing the dose and may result in an incorrect dose.
In case of overdose, contact your doctor, pharmacist or nurse immediately. Quick medical attention is important for adults and children even if you do not notice any signs or symptoms.
Parts of the ADCIRCA oral suspension administration system
Medicine
Medicine bottle Oral syringe Plunger Flange Syringe tip
Adaptor
Child-resistant cap
Lift and Peel Seal
STEP 1: PREPARE THE BOTTLE
1a
Gather the medicine bottle and adaptor.
Wash your hands with soap and water.
1b
Remove the cap from the bottle.
Firmly push the cap down while twisting it counter clockwise. Remove the cap from the bottle.
1c
Prior to first use only, remove the lift and peel seal.
Make sure the seal is completely removed.
1d
Prior to the first use only, push the adaptor all the way down into the opening of the bottle.
The adaptor represents a CHOKING HAZARD – small parts. It must be inserted completely into the bottle for safe use.
Do not attach the oral syringe to the adaptor until the adaptor is fully inserted into the bottle.
Do not twist the adaptor.
1e
Screw the cap back on the bottle tightly.
The cap will fit over the adaptor.
STEP 2: PREPARE THE DOSE
2a
Gather the medicine bottle with the adaptor inserted and oral syringe.
Make sure the cap is on tightly.
Wash your hands with soap and water.
2b
Shake the bottle.
Shake the medicine bottle well for at least 10 seconds before each use to fully mix the suspension.
Shake again if the bottle sits longer than 15 minutes.
2c Remove the cap from the bottle.
2d
Firmly insert the oral syringe into the opening of the adaptor.
Make sure that the syringe tip is fully inside the adaptor and the plunger is pushed all the way to the syringe tip.
2e
Turn the bottle with the oral syringe upside down while holding the syringe in place.
Make sure that the bottle is upside down.
Make sure the oral syringe stays completely inserted in the adaptor.
2f
Draw the dose.
Slowly pull the plunger down until the mL graduation mark is visible below the bottom of the flange for the dose prescribed for your child.
The graduation mark is located on the plunger of the oral syringe.
Make sure the top edge of the graduation mark is aligned to the bottom of the flange.
2g
Turn the bottle upright and check closely for air gaps in the oral syringe.
An air gap may result in an incorrect dose.
The medicine is white, the same colour as the oral syringe. Air gaps may be difficult to see.
If there is an air gap, empty the medicine back into the bottle and repeat steps 2e through 2g.
2h
Remove the oral syringe from the bottle.
Do not touch the plunger.
STEP 3: GIVE THE DOSE
Put the oral syringe into a corner of your child’s mouth. Tell your child not to bite the syringe.
Do not squirt the medicine into the back of the throat. Slowly and gently push down the plunger to the end of the syringe so that all of the medicine is in your child’s mouth. Make sure your child swallows all of the medicine.
STEP 4: CLEAN UP
4a
Screw the cap back on the bottle tightly.
Do not remove the adaptor. The cap will fit over it.
4b
Fill the oral syringe with clean water.
Do not wash the oral syringe with soap or detergent.
Do not remove the plunger from the oral syringe. Fill a cup with clean water, insert the oral syringe, and pull the plunger up to fill the syringe with water.
4c
Push the plunger down and squirt the water into the cup or into the sink.
Make sure to remove the water from the oral syringe. Shake excess water from the syringe and dry it with a paper towel.
Store the oral syringe and bottle in the original carton. Wash your hands with soap and water.
DISPOSAL OF MEDICINE
Do not throw away any medicines via wastewater or household water. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
DISPOSAL OF SYRINGE
Ask your doctor, pharmacist or nurse how to dispose of your syringe.
HOW TO STORE YOUR MEDICINE
This medicine does not require any special storage conditions
Store the bottle standing upright.
Keep the bottle and oral syringe out of sight and reach of children.
COMMONLY ASKED QUESTIONS
Q. What if I see air gaps in my oral syringe?
A. Do not give the medicine. Air gaps may result in an incorrect dose. Empty the medicine back into the bottle and repeat steps 2e through 2g.
Q. What if there is too much medicine in the oral syringe?
A. Keep the syringe tip in the bottle. Hold the bottle upright. Push the plunger down until the correct dose is in the oral syringe.
Q. What if there is not enough medicine in the oral syringe?
A. Keep the syringe tip in the bottle. Hold the bottle upside down. Pull the plunger down until the correct dose is in the oral syringe.
Q. What if I get some medicine in my eye or in my child’s eye?
A. Flush the eye immediately with water and call your doctor, pharmacist or nurse. As soon as possible, wash hands and surfaces that may have come in contact with the medicine.
Q. How do I travel with this medicine?
A. Make sure you have enough medicine for the entire trip. Take the oral syringe and medicine in its original container. Store the medicine in a safe place upright.
Q. Can I mix this medicine with food or water before I give it to my child? A. It is not recommended to mix this medicine with food or water. This can affect the way the medicine tastes or prevent a full dose. You can give your child a glass of water to drink after he or she takes the entire dose of medicine.
Q. What if my child spits up the medicine?
A. Do not give additional medicine to your child. Contact your doctor, pharmacist or nurse.
Q. What if my child does not swallow all of the medicine?
A. Contact your doctor, pharmacist or nurse.
Q. What if my child swallows too much medicine?
A. Immediately contact your doctor, pharmacist or nurse.
FOR QUESTIONS OR MORE INFORMATION ABOUT ADCIRCA ORAL SUSPENSION For questions or more information about ADCIRCA
- Call your doctor, pharmacist or nurse
- Call Lilly
Read the full package leaflet for ADCIRCA inside this box to learn more about your medicine.
For questions or more information about ADCIRCA oral suspension
If you have any questions or problems with your oral suspension syringe, contact Lilly or your doctor, pharmacist or nurse for assistance. Report all MEDICAL DEVICE COMPLAINTS or UNDESIRABLE SIDE EFFECTS, including SUSPECTED SERIOUS INCIDENTS, to Lilly.