ISTIN 5 MG TABLETS - patient leaflet, side effects, dosage

MORE INFORMATION ON ISTIN

Package leaflet: Information for the user

Not known: frequency cannot be estimated from the available data

• Trembling, rigid posture, mask-like face, slow movements and a shuffling, unbalanced walk

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom

Yellow Card Scheme website: or search for MHRA Yellow Card in the Google Play or Apple App Store.

Malta

ADR Reporting

Website: adrportal

5. how to store istin

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 pack after ‘EXP’. The expiry date refers to the last day of that month.

Tablets

Do not store above 25°C.

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 Istin contains

The active substance in Istin 5 mg tablets is amlodipine (as besilate).

The active substance in Istin 10 mg tablets is amlodipine (as besilate).

The other ingredients are calcium hydrogen phosphate anhydrous, magnesium stearate, microcrystalline cellulose and sodium starch glycolate Type A.

What Istin looks like and contents of the pack

5 mg tablets: White to off-white, emeraldshaped tablets engraved AML 5 and

Upjohn UK Limited Sandwich, England

breaker score on one side and Pfizer logo on the other side.

10 mg tablets: White to off-white, emeraldshaped tablets engraved AML-10 on one side and Pfizer logo on the other side. Istin 5 mg tablets are available in blisters containing 4, 10, 14, 20, 28, 30, 50, 60, 98, 100, 300, 500 tablets, calendar packs containing 28 and 98 tablets and in unit dose blister strips containing 50×1 and 500×1 tablets. Istin 10 mg tablets are available in blisters containing 4, 10, 14, 20, 28, 30, 50, 60, 90, 98, 100, 300, 500 tablets, calendar packs containing 28 and 98 tablets and in unit dose blister strips containing 50×1 and 500×1 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder Upjohn UK Limited

Ramsgate Road Sandwich

Kent

CT13 9NJ

United Kingdom

Manufacturer

Pfizer Manufacturing Deutschland GmbH Betriebsstatte Freiburg Mooswaldallee 1

79090 Freiburg, Germany

This medicinal product is authorised in the Member States of the EEA under the following names:

Tablets:

Austria, Bulgaria, Denmark, Estonia, Finland, Germany, Hungary, Iceland, Italy, Latvia, Lithuania, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Sweden: Norvasc Czech Republic: Zorem

Ireland, Malta, United Kingdom: Istin Ireland: Amlodipine Upjohn

Italy: Amlodipina Pfizer Italia

Spain: Norvas 5 mg comprimidos, Norvas 10 mg comprimidos

United Kingdom: Amlodipine

This leaflet was last revised in 04/2021.

Ref: IS 32_0

Other sources of information

Detailed information on this medicinal product is available on the website of the Medicines & Healthcare Products Regulatory Agency.

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Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• – Keep this leaflet. You may need to read it again.

• – If you have any further questions, ask your doctor or pharmacist.

• – This medicine has been prescribed for you only. Do not pass it on to others.

It may harm them, even if their signs of illness are the same as yours.

- if you get any side effects, talk to your doctor, pharmacist or nurse. this includes any possible side effects not listed in this leaflet. see section 4.

What is in this leaflet :

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

• 2. What you need to know before you take Istin

• 3. How to take Istin

• 4. Possible side effects

• 5. How to store Istin

• 6. Contents of the pack and other information

1. what istin is and what it is used for

Istin contains the active substance amlodipine which belongs to a group of medicines called calcium antagonists.

Istin is used to treat high blood pressure (hypertension) or a certain type of chest pain called angina, a rare form of which is Prinzmetal’s or variant angina.

In patients with high blood pressure this medicine works by relaxing blood vessels, so that blood passes through them more easily. In patients with angina Istin works by improving blood supply to the heart muscle which then receives more oxygen and as a result chest pain is prevented. This medicine does not provide immediate relief of chest pain from angina.

UNITED KINGDOM

2. what you need to know before you take istin

MORE INFORMATION ON ISTIN

MORE INFORMATION ON ISTIN

Istin may affect or be affected by other medicines, such as:

• ketoconazole, itraconazole (antifungal medicines)
• ritonavir, indinavir, nelfinavir (so called protease inhibitors used to treat HIV)
• rifampicin, erythromycin, clarithromycin (antibiotics)
• hypericum perforatum (St. John’s Wort)
• verapamil, diltiazem (heart medicines)
• dantrolene (infusion for severe body temperature abnormalities)
• tacrolimus, sirolimus, temsirolimus, and everolimus (medicines used to alter the way your immune system works)
• simvastatin (cholesterol lowering medicine)
• cyclosporine (an immunosuppressant)

Istin may lower your blood pressure even more if you are already taking other medicines to treat your high blood pressure. Istin with food and drink

Grapefruit juice and grapefruit should not be consumed by people who are taking Istin. This is because grapefruit and grapefruit juice can lead to an increase in the blood levels of the active ingredient amlodipine, which can cause an unpredictable increase in the blood pressure lowering effect of Istin.

Pregnancy and breast-feeding Pregnancy

The safety of amlodipine in human pregnancy has not been established. If you think you might be pregnant, or are planning to get pregnant, you must tell your doctor before you take Istin.

Breast-feeding

Amlodipine has been shown to pass into breast milk in small amounts. If you are breast-feeding or about to start breastfeeding you must tell your doctor before taking Istin.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Istin may affect your ability to drive or use machines. If the tablets make you feel sick, dizzy or tired, or give you a headache, do not drive or use machines and contact your doctor immediately.

Istin contains sodium

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

3. how to take istin

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

The recommended initial dose is Istin 5 mg once daily. The dose can be increased to Istin 10 mg once daily.

This medicine can be used before or after food and drinks. You should take this medicine at the same time each day with a drink of water. Do not take Istin with grapefruit juice.

Use in children and adolescents

For children and adolescents (6–17 years old), the recommended usual starting dose is 2.5 mg a day. The maximum recommended dose is 5 mg a day.

Istin 5 mg tablets can be divided into halves to provide a 2.5 mg dose.

It is important to keep taking the tablets. Do not wait until your tablets are finished before seeing your doctor.

If you take more Istin than you should

Taking too many tablets may cause your blood pressure to become low or even dangerously low. You may feel dizzy, lightheaded, faint or weak. If blood pressure drop is severe enough shock can occur. Your skin could feel cool and clammy and you could lose consciousness. Seek immediate medical attention if you take too many Istin tablets.

If you forget to take Istin

Do not worry. If you forget to take a tablet, leave out that dose completely. Take your next dose at the right time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Istin

Your doctor will advise you how long to take this medicine. Your condition may return if you stop using this medicine before you are advised.

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.

Visit your doctor immediately if you experience any of the following side effects after taking this medicine.

• Sudden wheeziness, chest pain, shortness of breath or difficulty in breathing
• Swelling of eyelids, face or lips
• Swelling of the tongue and throat which causes great difficulty breathing
• Severe skin reactions including intense skin rash, hives, reddening of the skin over your whole body, severe itching, blistering, peeling and swelling of the skin, inflammation of mucous membranes (Stevens Johnson Syndrome, toxic epidermal necrolysis) or other allergic reactions
• Heart attack, abnormal heart beat
• I nflamed pancreas which may cause severe abdominal and back pain accompanied with feeling very unwell

The following very common side effect has been reported. If this causes you problems or if it lasts for more than one week , you should contact your doctor.

Very common: may affect more than 1 in 10 people

• Oedema (fluid retention)

The following common side effects have been reported. If any of these cause you problems or if they last for more than one week , you should contact your doctor.

Common: may affect up to 1 in 10 people

• Headache, dizziness, sleepiness (especially at the beginning of treatment)
• Palpitations (awareness of your heart beat), flushing
• Abdominal pain, feeling sick (nausea)
• Altered bowel habits, diarrhoea, constipation, indigestion
• Tiredness, weakness
• Visual disturbances, double vision
• Muscle cramps
• Ankle swelling

Other side effects that have been reported include the following list. If any of these get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Uncommon: may affect up to 1 in 100 people

• Mood changes, anxiety, depression, sleeplessness
• Trembling, taste abnormalities, fainting
• Numbness or tingling sensation in your limbs, loss of pain sensation
• Ringing in the ears
• Low blood pressure
• Sneezing/running nose caused by inflammation of the lining of the nose (rhinitis)
• Cough
• Dry mouth, vomiting (being sick)
• Hair loss, increased sweating, itchy skin, red patches on skin, skin discolouration
• Disorder in passing urine, increased need to urinate at night, increased number of times of passing urine
• I nability to obtain an erection, discomfort or enlargement of the breasts in men
• Pain, feeling unwell
• Joint or muscle pain, back pain
• Weight increase or decrease

Rare: may affect up to 1 in 1,000 people

• Confusion

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

• Decreased numbers of white blood cells, decrease in blood platelets which may result in unusual bruising or easy bleeding
• Excess sugar in blood (hyperglycaemia)
• A disorder of the nerves which can cause muscular weakness, tingling or numbness
• Swelling of the gums
• Abdominal bloating (gastritis)
• Abnormal liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice), liver enzyme increase which may have an effect on some medical tests
• Increased muscle tension
• I nflammation of blood vessels, often with skin rash
• Sensitivity to light
• Disorders combining rigidity, tremor, and/or movement disorders

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