Patient leaflet - Istin 10 mg tablets
1. What Istin is and what it is used for
Pfizer Manufacturing Deutschland GmbH Betriebsstätte Freiburg
2. What you need to know before you
Warnings and precautions
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.
Talk to your doctor or pharmacist before taking Istin.
take Istin
Mooswaldallee 1
3. How to take Istin
79090 Freiburg,
You should inform your doctor if you have or have had any of the following conditions:
4. Possible side effects
Germany
5. How to store Istin
Tablets
This medicinal product is authorised in the Member States of the EEA under the following names:
6. Contents of the pack and other
Do not store above 25°C.
- Recent heart attack
information
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.
- Heart failure
- Severe increase in blood pressure
- What Istin is and what it is used for
Tablets:
(Hypertensive crisis)
Austria, Bulgaria, Denmark, Estonia, Finland, Germany, Hungary, Iceland, Italy, Latvia, Lithuania, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Sweden: Norvasc Czech Republic: Zorem
- Liver disease
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.
- You are elderly and your dose needs to be increased
Contents of the pack and other information
Children and adolescents
Istin has not been studied in children under the age of 6 years. Istin should only be used for hypertension in children and adolescents from 6 years to 17 years of age (see section 3).
Ireland, Malta, United Kingdom: Istin Ireland: Amlodipine Upjohn
Italy: Amlodipina Pfizer Italia
What Istin contains
Spain: Norvas 5 mg comprimidos, Norvas 10 mg comprimidos
The active substance in Istin 5 mg tablets is amlodipine (as besilate).
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: Amlodipine
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.
For more information, talk to your doctor.
This leaflet was last revised in 04/2021. Ref: IS 32_0
Other medicines and Istin
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Other sources of information
Detailed information on this medicinal product is available on the website of the Medicines & Healthcare Products Regulatory Agency.
What Istin looks like and contents of the pack
5 mg tablets: White to off-white, emerald-shaped tablets engraved AML 5 and
mock up 8299 mock up 8299
Upjohn UK Limited
YOU WILL FIND MORE ABOUT
Sandwich, England
and/or movement disorders MORE INFORMATION ON ISTIN MORE INFORMATION ON ISTIN
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.
- 3.
How to take Istin
- 4. Possible side effects
- •
ketoconazole, itraconazole (anti-
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
fungal medicines)
- •
ritonavir, indinavir, nelfinavir (so called
protease inhibitors used to treat HIV)
Uncommon: may affect up to 1 in 100 people
- •
rifampicin, erythromycin,
Visit your doctor immediately if you experience any of the following side effects after taking this medicine.
clarithromycin (antibiotics)
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.
- Mood changes, anxiety, depression,
- •
hypericum perforatum (St. John’s
sleeplessness
Wort)
- Trembling, taste abnormalities, fainting
- Sudden wheeziness, chest pain,
- •
verapamil, diltiazem (heart medicines)
- Numbness or tingling sensation in
shortness of breath or difficulty in breathing
dantrolene (infusion for severe body
your limbs, loss of pain sensation • Ringing in the ears
temperature abnormalities)
- Swelling of eyelids, face or lips
tacrolimus, sirolimus, temsirolimus, and
- Low blood pressure
- Swelling of the tongue and throat
everolimus (medicines used to alter the way your immune system works)
- Sneezing/running nose caused by
which causes great difficulty breathing
inflammation of the lining of the nose (rhinitis)
Use in children and adolescents
simvastatin (cholesterol lowering
- Severe skin reactions including
medicine)
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.
- Cough
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
cyclosporine (an
- Dry mouth, vomiting (being sick)
immunosuppressant)
- Hair loss, increased sweating, itchy
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
skin, red patches on skin, skin discolouration
- Disorder in passing urine, increased need to urinate at night, increased number of times of passing urine
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
- Inability to obtain an erection,
Heart attack, abnormal heart beat
discomfort or enlargement of the breasts in men
- Inflamed pancreas which may cause
If you take more Istin than you should
severe abdominal and back pain accompanied with feeling very unwell
- Pain, feeling unwell
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
- Joint or muscle pain, back pain • Weight increase or decrease
unpredictable increase in the blood pressure lowering effect of Istin. Pregnancy and breast-feeding
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.
Rare: may affect up to 1 in 1,000 people
- Confusion
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
Very rare: may affect up to 1 in 10,000 people
consciousness. Seek immediate medical attention if you take too many Istin tablets.
Very common: may affect more than 1 in 10 people
- Decreased numbers of white blood cells, decrease in blood platelets which may result in unusual bruising or easy bleeding
- 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.
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.
Amlodipine has been shown to pass into breast milk in small amounts. If you are breast-feeding or about to start breast-feeding you must tell your doctor before taking Istin.
- Excess sugar in blood (hyperglycaemia)
- A disorder of the nerves which can cause muscular weakness, tingling or numbness
Common: may affect up to 1 in 10 people
- Swelling of the gums
- Abdominal bloating (gastritis)
Ask your doctor or pharmacist for advice before taking any medicine.
If you stop taking Istin
Headache, dizziness, sleepiness
- Abnormal liver function,
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.
(especially at the beginning of treatment)
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
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
Palpitations (awareness of your
heart beat), flushing
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
- Abdominal pain, feeling sick (nausea)
Altered bowel habits, diarrhoea,
Inflammation of blood vessels, often constipation, indigestion
with skin rash
Tiredness, weakness
- Sensitivity to light
- Visual disturbances, double vision • Muscle cramps
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
- Disorders combining rigidity, tremor,
- Ankle swelling
YOU WILL FIND MORE ABOUT
UNITED KINGDOM ISTIN ON THE BACK OF THIS LEAFLET
YOU WILL FIND MORE ABOUT
UNITED KINGDOM ISTIN ON THE BACK OF THIS LEAFLET