Amlodipine Tecnigen

Patient Information Leaflet

AMLODIPINE TECNIGEN
5 mg tablets
10 mg tablets
Amlodipine
Generic 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. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Amlodipine Tecnigen contains the active substance amlodipine, which belongs to a group of medicines called calcium channel blockers (calcium antagonists).
Amlodipine Tecnigen is used to treat high blood pressure (hypertension) or a type of chest pain known as angina, including a rare form called Prinzmetal's (or variant) angina.
In patients with high blood pressure, this medicine works by relaxing blood vessels, allowing blood to flow more easily. In patients with angina, Amlodipine Tecnigen improves blood supply to the heart muscle, thereby increasing oxygen delivery and preventing chest pain. This medicine does not provide immediate relief from angina-related chest pain.

2. What you need to know before taking

Amlodipine Tecnigen
Do not take Amlodipine Tecnigen

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

Take special care with Amlodipine Tecnigen
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 (hepatopathy)
• You are elderly and your dosage needs to be increased

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

• ketoconazole, itraconazole (antifungal medicines)
• ritonavir, indinavir, nelfinavir (so-called protease inhibitors used in the treatment of HIV)
• rifampicin, erythromycin, clarithromycin (antibiotics)
• Hypericum perforatum (St. John's wort)
• verapamil, diltiazem (heart medicines)
• dantrolene (infusion for severe disturbances in body temperature)
• simvastatin (cholesterol-lowering medicine)

Amlodipine Tecnigen may lower blood pressure even more if you are already taking other medicines for the treatment of hypertension.
Amlodipine Tecnigen with food and drink
People taking Amlodipine Tecnigen should not drink grapefruit juice, as grapefruit and its juice may increase blood levels of the active substance amlodipine, which could lead to an increased hypotensive effect of Amlodipine Tecnigen.
Pregnancy and breastfeeding
Pregnancy The safety of amlodipine in pregnant women has not been established. If
you think you are pregnant or are planning a pregnancy, inform your doctor before
taking Amlodipine Tecnigen.
Breastfeeding
It is not known whether amlodipine passes into breast milk. If you are breastfeeding or plan to breastfeed, inform your doctor before taking Amlodipine Tecnigen.
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or
are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Amlodipine Tecnigen may affect your ability to drive or use machinery.
If the tablets cause you discomfort, dizziness or fatigue, or if you experience headache, avoid driving or using machinery and contact your doctor immediately.
Amlodipine Tecnigen contains lactose.
This medicine contains lactose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Amlodipina Tecnigen

Take this medicine exactly as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The recommended starting dose is Amlodipina Tecnigen 5 mg once daily. The dose may be increased to Amlodipina Tecnigen 10 mg once daily.
This medicine can be taken before or after food and drinks. You must take the medicine every day at the same time, with a glass of water. Do not take Amlodipina Tecnigen with grapefruit juice.

Use in children and adolescents
For children and adolescents (aged 6 to 17 years), the usual starting dose is 2.5 mg daily. The maximum recommended daily dose is 5 mg. Amlodipina 2.5 mg is not currently available, and the 2.5 mg dose can be achieved using Amlodipina Tecnigen 5 mg tablets, which can be divided into equal parts.

Continue taking the tablets for as long as your doctor has instructed. Contact your doctor before stopping the tablets.

If you take more Amlodipina Tecnigen than you should
If you take too many tablets, your blood pressure may drop too low, which could be dangerous. You may experience dizziness, lightheadedness, weakness, or fainting. The drop in blood pressure could be so severe as to cause shock. Your skin may become cold and clammy, and you may lose consciousness.
If you have taken an excessive number of Amlodipina Tecnigen tablets, contact your doctor immediately.

If you forget to take Amlodipina Tecnigen
Do not worry. If you forget to take a tablet, skip the missed dose. Take the next tablet at your usual time. Do not take a double dose to make up for the forgotten tablet.

If you stop taking Amlodipina Tecnigen
You must continue taking the medicine for as long as your doctor has told you to.
Stopping treatment may cause your condition to worsen.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If you notice any of the following very rare and serious side effects, consult your doctor immediately:

• Sudden onset of shortness of breath, chest pain, breathlessness, or difficulty breathing.
• Swelling of the eyelids, face, or lips.
• Swelling of the tongue and throat which may cause difficulty breathing.
• Severe skin reactions including intense skin rash, hives, widespread skin redness, severe itching, blisters, skin peeling and swelling, inflammation of mucous membranes (Stevens-Johnson syndrome), or other allergic reactions.
• Myocardial infarction, arrhythmia.
• Inflammation of the pancreas which may cause severe abdominal and back pain associated with a strong feeling of malaise.

The following common side effects have been reported. If any of these occur, or if they persist for more than one week, consult your doctor.
Common: may occur in 1 to 10 out of 100 patients:

• Headache, dizziness, drowsiness (especially at the beginning of treatment).
• Palpitations (awareness of heartbeat), flushing.
• Abdominal pain, nausea.
• Swelling of the ankles (oedema), fatigue.

In addition, the following side effects have been reported.
If any of these side effects worsen, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist.
Uncommon: may occur in 1 to 10 out of 1,000 patients:

• Mood changes, anxiety, depression, insomnia.
• Tremor, taste disturbances, fainting, weakness.
• Numbness or tingling sensation in limbs; loss of pain sensation.
• Visual disturbances, double vision, ringing in the ears (tinnitus).
• Low blood pressure.
• Sneezing/runny nose due to inflammation of the nasal mucosa (rhinitis).
• Changes in bowel habits, diarrhoea, constipation, indigestion, dry mouth, vomiting.
• Hair loss, increased sweating, skin itching, red skin patches, skin discoloration.
• Urinary disorders, need to urinate at night, frequent need to urinate.
• Inability to achieve an erection; discomfort or breast enlargement in men.
• Weakness, pain, malaise.
• Joint or muscle pain, muscle cramps, back pain.
• Weight gain or loss.

Rare: may occur in 1 to 10 out of 10,000 patients:

• Confusion.

Very rare: may occur in less than 1 out of 10,000 patients:

• Low levels of white blood cells and platelets in the blood which may lead to unusual bruising or tendency to bleed (damage to red blood cells).
• High blood sugar levels (hyperglycaemia).
• A nerve disorder which may cause weakness, tingling, or numbness.
• Cough, gum swelling.
• Abdominal swelling (gastritis).
• Abnormal liver function, liver inflammation (hepatitis), yellowing of the skin (jaundice), increased liver enzymes which may lead to changes in certain laboratory tests.
• Increased muscle tension.
• Inflammation of blood vessels, often associated with skin rash.
• Light sensitivity.
• Disorders related to stiffness, tremor, and/or movement disturbances.

If any of the side effects worsen, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at:
www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Amlodipine Tecnigen

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after
Exp. The expiry date refers to the last day of that month.
Store below 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. This will help
protect the environment.

6. Package contents and other information

What Amlodipine Tecnigen contains
The active substance is amlodipine (as besilate).
The other components are: Microcrystalline cellulose, monohydrate lactose, sodium starch glycolate, magnesium stearate.

Description of the appearance of Amlodipine Tecnigen and contents of the pack
White, round, flat tablets with a score line on one side.
Amlodipine Tecnigen 5 mg tablets are available in blisters containing 28 divisible tablets.
Amlodipine Tecnigen 10 mg tablets are available in blisters containing 14 divisible tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
TECNIGEN SRL
Via Galileo Galilei 40, 20092 Cinisello Balsamo - Milano

Manufacturer
West Pharma Producoes de Especialidades Farmaceuticas SA
Rua Joao de Deus, 11 - Venda Nova
Amadora (Portugal)
Or
Atlantic Pharma - Produções Farmacêuticas, S.A.
Rua da Tapada Grande, n.° 2, Abrunheira, 2710-089
Sintra
Portugal

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