Amlodipine Teva

Patient information leaflet

AMLODIPINE TEVA 5 mg tablets, 10 mg tablets

Equivalent medicine
Please read all of this leaflet carefully before you start taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What Amlodipine Teva is and what it is used for
2. What you need to know before taking Amlodipine Teva
3. How to take Amlodipine Teva
4. Possible side effects
5. How to store Amlodipine Teva
6. Contents of the pack and other information

1. What Amlodipine Teva is and what it is used for

Amlodipine Teva contains the active substance amlodipine, which belongs to a group of medicines called calcium antagonists.
Amlodipine Teva is used to treat high blood pressure (hypertension) or a particular type of chest pain called angina, of which Prinzmetal's or variant angina is a rare form.
In patients with high blood pressure, this medicine works by relaxing the blood vessels and making it easier for blood to flow through them. In patients with angina, Amlodipine Teva improves blood supply to the heart muscle, thereby delivering more oxygen; this helps prevent the occurrence of chest pain. This medicine does not provide immediate relief of chest pain caused by angina.

2. What you need to know before taking Amlodipine Teva

Do not take Amlodipine Teva

• if you are allergic (hypersensitive) to amlodipine, to any of the other ingredients of this medicine listed in section 6, or to any other calcium antagonist. Symptoms may include itching, skin redness, or difficulty breathing;
• if you have severe low blood pressure (hypotension);
• if you have narrowing of the aortic heart valve (aortic stenosis) or cardiogenic shock (a condition in which the heart is unable to supply sufficient blood to the body);
• if you have heart failure following a heart attack.

Warnings and precautions
Talk to your doctor or pharmacist before taking Amlodipine Teva.
You must inform your doctor if you have or have had any of the following conditions:

• recent heart attack;
• heart failure;
• severe high blood pressure (hypertensive crisis);
• liver disease;
• if you are elderly and your dose needs to be increased.

Children and adolescents
Amlodipine Teva has not been studied in children under 6 years of age. In children and adolescents aged between 6 and 17 years, Amlodipine Teva should only be used for hypertension (see section 3).
For further information, consult your doctor.
Other medicines and Amlodipine Teva
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
Amlodipine Teva may affect other medicines or be affected by other medicines, such as:

• ketoconazole, itraconazole (antifungal medicines);
• ritonavir, indinavir, nelfinavir (called protease inhibitors, used to treat HIV);
• rifampicin, erythromycin, clarithromycin (antibiotics);
• Hypericum perforatum (St. John's wort);
• verapamil, diltiazem (medicines for the heart);
• dantrolene (infusion for severe body temperature abnormalities);
• tacrolimus, sirolimus, temsirolimus, and everolimus (medicines used to modify the way the immune system works);
• simvastatin (a medicine to lower cholesterol);
• ciclosporin (an immunosuppressant).

Amlodipine Teva may further lower your blood pressure if you are already taking other medicines for the treatment of hypertension.
Amlodipine Teva with food and drink
People taking Amlodipine Teva should not consume grapefruit or grapefruit juice.
Grapefruit and grapefruit juice may increase blood levels of the active substance amlodipine, which could lead to an unpredictable increase in the blood pressure-lowering effect of Amlodipine Teva.
Pregnancy and breastfeeding
Pregnancy
The safety of amlodipine during pregnancy has not been established. If you suspect you are pregnant or are planning a pregnancy, you must inform your doctor before taking Amlodipine Teva.
Breastfeeding
It has been shown that amlodipine passes into breast milk in small amounts. If you are breastfeeding or are about to start, you must inform your doctor before taking Amlodipine Teva.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Amlodipine Teva may affect your ability to drive or operate machinery. If the tablets cause you to feel unwell, dizzy, tired, or give you headaches, do not drive or operate machinery and contact your doctor immediately.
Amlodipine Teva contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially “sodium-free”.

3. How to take Amlodipine Teva

Take this medicine exactly as your doctor or pharmacist has told you. If you have any doubts, consult your doctor or pharmacist.
The recommended starting dose is 5 mg of Amlodipine Teva once daily. The dose may be increased to 10 mg of Amlodipine Teva once daily.
This medicine can be taken before or after food and drink. You should take this medicine at the same time each day, with a glass of water. Do not take Amlodipine Teva with grapefruit juice.

Use in children and adolescents
For children and adolescents (aged between 6 and 17 years), the usual recommended starting dose is 2.5 mg daily. The maximum recommended dose is 5 mg daily.
The 5 mg Amlodipine Teva tablets may be divided into two equal parts to achieve a 2.5 mg dose.
It is important to continue taking the tablets. Do not wait until the tablets are finished before contacting your doctor.

If you take more Amlodipine Teva than you should
Taking too many tablets may cause excessive lowering of blood pressure, sometimes to dangerous levels. You may feel dizzy, lightheaded, faint, or weak. If the drop in blood pressure is very severe, shock may occur. Your skin may feel cold and clammy and you may lose consciousness. If you take too many Amlodipine Teva tablets, seek immediate medical attention.
Fluid may accumulate excessively in the lungs (pulmonary edema), causing breathlessness, which may develop up to 24–48 hours after ingestion.

If you forget to take Amlodipine Teva
Do not worry. If you forget to take a tablet, simply skip that dose completely. Take the next dose at the usual time. Do not take a double dose to make up for the missed dose.

If you stop taking Amlodipine Teva
Your doctor will tell you how long you should take this medicine. Your condition may return if you stop taking the medicine earlier than advised.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Contact your doctor immediately if you experience any of the following side effects after taking this medicine:

• Sudden onset of wheezing, chest pain, shortness of breath, or difficulty breathing
• Swelling of the eyelids, face, or lips
• Swelling of the tongue and throat, which may cause severe breathing difficulties
• Severe skin reactions, including severe rash, hives, widespread skin redness, intense itching, blistering, skin peeling and swelling, mucosal inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis), or other allergic reactions
• Heart attack, irregular heartbeat
• Inflammation of the pancreas, which may cause severe abdominal and back pain associated with a strong feeling of malaise

The following very common side effect has been reported. If this side effect causes you problems or persists for more than one week, consult your doctor.
Very common: may affect more than 1 in 10 people

• Edema (fluid retention)

The following common side effects have also been reported. If any of these cause you problems or persist for more than one week, consult your doctor.
Common: may affect up to 1 in 10 people

• Headache, dizziness, drowsiness (especially at the beginning of treatment)
• Palpitations (awareness of your heartbeat), flushing
• Abdominal pain, nausea
• Changes in bowel habits, diarrhoea, constipation, indigestion
• Fatigue, weakness
• Visual disturbances, double vision
• Muscle cramps
• Swelling of the ankles

In addition, the following side effects have been reported. If any of these worsen or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.
Uncommon: may affect up to 1 in 100 people

• Mood changes, anxiety, depression, insomnia
• Tremor, taste disturbances, fainting
• Sensation of numbness or tingling in the limbs, loss of pain sensitivity
• Ringing in the ears
• Low blood pressure
• Sneezing/runny nose due to inflammation of the nasal mucosa (rhinitis)
• Cough
• Dry mouth, vomiting
• Hair loss, increased sweating, skin itching, red patches on the skin, changes in skin colour
• Urinary problems, increased need to urinate at night, increased frequency of urination
• Inability to achieve erection, discomfort or breast enlargement in men
• Pain, feeling of malaise
• Joint or muscle pain, back pain
• Weight gain or weight loss

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

• Confusion

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

• Decreased number of white blood cells, decreased number of platelets in the blood, which may lead to unusual bruising or bleeding tendency
• High blood sugar levels (hyperglycaemia)
• A nerve disorder that may cause muscle weakness, tingling, or numbness
• Swollen gums, bleeding gums
• Abdominal swelling (gastritis)
• Abnormal liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice), increased liver enzymes which may affect certain clinical tests
• Increased muscle tension
• Inflammation of blood vessels, often associated with a skin rash
• Light sensitivity
• Conditions involving stiffness, tremor, and/or movement disorders

Not known: frequency cannot be estimated from the available data

• Tremor, rigid posture, mask-like facial expression, slow movements, and shuffling gait

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Amlodipine Teva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, blister, or bottle label after Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage temperature.
Store in the original packaging to protect the medicine from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.

6. Package contents and other information

What Amlodipine Teva contains

• The active substance is amlodipine. Each tablet contains amlodipine besylate equivalent to 5 mg or 10 mg of amlodipine.
• The other ingredients are: calcium hydrogen phosphate, microcrystalline cellulose, sodium starch glycolate type A and magnesium stearate.

Description of the appearance of Amlodipine Teva and package contents
Amlodipine Teva 5 mg tablets are available as round tablets (approximately 7.50 mm in diameter), white to almost white in colour, with "TV" engraved on one side and "5" and a score line on the other side.
Amlodipine Teva 10 mg tablets are available as round tablets (approximately 9.50 mm in diameter), white to almost white in colour, with "TV" engraved on one side and "10" and a score line on the other side.
Amlodipine Teva is available in blisters containing 14, 20, 28, 30, 50, 56, 60, 90, 98, 100 and 120 tablets and in bottles containing 100, 120, 200 and 250 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
TEVA B.V. - Swensweg 5 - 2031 GA Haarlem - The Netherlands

Manufacturer
Teva Pharmaceutical Works Private Limited Company Pallagi út 13, Debrecen 4042 Hungary