What is amlodipine

Amlodipine (besilat) Dexcel 5mg tablets

Patient information sheet for Amlodipine (besilat) Dexcel 5mg tablets

1. What is Amlodipine (besilat) Dexcel 5mg tablets and what is it used for?

1.1 What are the properties of the medicinal product?

Amlodipin (besilat) Dexcel 5mg tablets contains the active ingredient amlodipin, a drug from the group of so-called calcium antagonists.

Amlodipine has antihypertensive and blood circulation-enhancing properties.

Amlodipine is usually used in salt form as amlodipine besylate, maleate or mesilate.

Amlodipine requires a prescription and should only be used on medical advice.

1.2 What strengths and dosage forms are there?

Amlodipine is usually available as

- 5 mg, 7.5 mg and 10 mg tablets.

Your doctor will determine which strength and dosage form are suitable for your treatment.

1.3 Amlodipine is used

- to treat high blood pressure (hypertension),

- to treat a type of chest pain called angina pectoris or, more rarely, vasospastic (Prinzmetal) angina.

2. What you need to know before you take Amlodipine (besilat) Dexcel 5mg tablets?

2.1 Amlodipin (besilat) Dexcel 5mg tablets must not be used

- if you are allergic to amlodipine, any of the other ingredients of this medicine or any other calcium channel blockers. This can manifest as itching, reddening of the skin, or difficulty breathing.

- if you have severely low blood pressure (hypotension).

- if you suffer from severe narrowing of the outflow tract in the left ventricle of the heart (aortic stenosis) or from cardiogenic shock (in which case your heart can no longer supply the body with enough blood).

- if you have heart failure after a heart attack.

2.2 Special care is required when taking Amlodipine (besilat) Dexcel 5mg tablets

Tell your doctor if any of the following applies to you, or if they did:

- if you have recently had a heart attack

- if you suffer from heart failure,

- if you suffer from a sharp rise in blood pressure (hypertensive crisis),

- if you have a liver disease,

- if you are elderly and your dose needs to be increased.

2.2.a) Children

Amlodipine has not been studied in children under 6 years of age. Therefore, amlodipine should only be used in children and adolescents with high blood pressure aged 6 to 17 years.

Please speak to your doctor for further information.

2.2.b) Elderly patients

The usual doses are recommended in the elderly, but the dose should be increased with caution.

2.2.c) Pregnancy

The safety of Amlodipine (besilat) Dexcel 5mg tablets during pregnancy has not been established. If you think you may be pregnant or plan to become pregnant you must tell your doctor before taking Amlodipine (besilat) Dexcel 5mg tablets.

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

2.2.d) Breastfeeding

It is not known whether amlodipine is excreted in breast milk. If you are breast-feeding or about to start breast-feeding you must tell your doctor before taking Amlodipine (besilat) Dexcel 5mg tablets.

2.2.e) Ability to drive and use machines

The ability to actively drive or use machines can be impaired by Amlodipine (besilat) Dexcel 5 mg tablets. If the tablets make you feel sick, dizzy or tired, or if you develop a headache, do not drive or use machines and contact your doctor immediately.

2.3 Interactions with other medicinal products

Tell your doctor or pharmacist if you are taking / using, have recently taken / used or may take / use any other medicines.

Amlodipine (besilat) Dexcel 5mg tablets may affect or be affected by other medicines such as:

- ketoconazole, itraconazole (for fungal infections)

- ritonavir, indinavir, nelfinavir (so-called protease inhibitors against HIV infections)

- rifampicin, erythromycin, clarithromycin (antibiotics)

- Hypericum perforatum (St. John's wort)

- verapamil, diltiazem (heart medicines)

- dantrolene (an infusion used for severe temperature changes)

- simvastatin (medicine used to lower high levels of fat in the blood).

Amlodipine (besilat) Dexcel 5mg tablets can lower your blood pressure even further if you are already taking other antihypertensive medicines.

2.4 What should be thought of when taking Amlodipine (besilat) Dexcel 5mg tablets together with food, beverages and tobacco?

People who take Amlodipine (besilat) Dexcel 5mg tablets should not eat grapefruit or drink grapefruit juice, as this can increase the blood level of the active ingredient amlodipine, which may lead to an uncontrolled increase in the blood pressure lowering effect of Amlodipine (besilat) Dexcel 5mg tablets .

3. How to take Amlodipine (besilat) Dexcel 5mg tablets?

Always take Amlodipine (besilat) Dexcel 5mg tablets exactly as your doctor has told you. Please ask your doctor or pharmacist if you are not sure.

3.1 Type of application

Amlodipin (besilat) Dexcel 5mg tablets can be taken with or without food or drink. You should take your medicine with a glass of water at the same time each day. Amlodipine (besilat) Dexcel 5mg tablets must not be taken with grapefruit juice.

The duration of the usage will be decided by the medicating doctor. There is no specific time limit. It is important that you take the tablets regularly. Do not wait until the tablets are finished before contacting your doctor.

Please talk to your doctor if you have the impression that the effect of Amlodipine (besilat) Dexcel 5mg tablets is too strong or too weak.

3.2 Unless otherwise prescribed by the doctor, the usual dose is

3.2.a) Adults

The usual starting dose is 5 mg once a day. The dose can be increased to 10 mg once a day.

3.2.b) Use in children and adolescents

For children and adolescents aged 6 to 17 years, the recommended usual starting dose is 2.5 mg daily. The maximum recommended dose is 5 mg daily. Amlodipine 2.5 mg is not currently available, and the 2.5 mg dosage usually cannot be obtained with the 5 mg tablets as they are not made to be split into equal halves.

3.3 If you take more Amlodipine (besilat) Dexcel 5mg tablets than you should

If you have taken too many tablets, your blood pressure may drop or become dangerously low. You may feel dizzy, light-headed, weak, or passed out. If the drop in blood pressure is severe enough, shock can occur. Your skin may feel cold and clammy and you could lose consciousness. Get medical surveillance immediately if you take too many tablets.

This is not a bad thing. If you forget a tablet, skip it completely. Then take the next dose at the usual time. Do not double the dose on your own to make up for a forgotten dose.

3.4 If you forget to take Amlodipine (besilat) Dexcel 5mg tablets

If you have taken too few Amlodipine (besilat) Dexcel 5mg tablets or have forgotten a dose, do so as soon as possible. However, if it is almost time to take the next dose, skip the missed dose and continue with your normal intake cycle. Do not double the dose on your own!

3.5 Effects if treatment with Amlodipine (besilat) Dexcel 5mg tablets is stopped

Your doctor will tell you how long to take your medicine. If you stop using your medicine before he has asked you to, your symptoms may return.

4. What are the possible side effects?

Like all medicines, Amlodipine (besilat) Dexcel 5mg tablets can cause side effects, although not everybody gets them.

When evaluating side effects, the following frequencies are used as a basis:

- very common: more than 1 in 10 people

- common: less than 1 in 10, but more than 1 in 100 patients

- uncommon: less than 1 in 100 but more than 1 in 1,000 patients

- rarely: less than 1 in 1,000 but more than 1 in 10,000 people treated

- very rare: less than 1 in 10,000 patients, including isolated cases

- Frequency not known: frequency cannot be calculated from the available data

4.1 Which side effects can occur in detail?

Contact your doctor immediately if you experience the following very rare, serious side effects after taking this medicine.

- Sudden wheezing when breathing, chest pain, shortness of breath or difficulty breathing

- swelling of the eyelids, face or lips

- Swelling of the tongue or throat, making it difficult to breathe

- Serious skin reactions including a severe rash, hives, reddening of the skin all over your body, severe itching, blistering, peeling and swelling of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome) or other allergic reactions

- Heart attack, unusual heartbeat

- Inflammation of the pancreas, which can lead to severe pain in the abdomen and back, which makes you feel unwell

The following common side effects have been reported. If any of these cause you significant problems or last for more than a week, you should see your doctor.

4.1.a) Often

Headache, dizziness, sleepiness (especially at the beginning of treatment), palpitations, reddening of the skin with sensation of warmth, abdominal pain, nausea, ankle swelling (edema), tiredness.

Other side effects that have been reported are listed below. If any of these affects you seriously, or if you notice any side effects not listed here, please inform your doctor or pharmacist.

4.1.b) Occasionally

Mood swings, anxiety, depression, insomnia, tremors, taste disturbances, brief loss of consciousness, feeling weak, decreased sensitivity to touch stimuli or tingling in the extremities, loss of pain sensation, visual disturbances, double vision, ringing in the ears, low blood pressure, sneezing / runny nose due to inflammation of the nasal mucosa ( Rhinitis), changes in bowel habits, diarrhea, constipation, indigestion, dry mouth, vomiting, hair loss, increased sweating, itchy skin, red spots on the skin, skin discoloration, urination disorders, increased urge to urinate at night, frequent urination, erectile dysfunction, enlargement of the mammary glands in men, Feeling weak, pain, discomfort, joint or muscle pain, muscle cramps, back pain, weight gain or weight loss.

4.1.c) Rarely


4.1.d) Very rare

Decrease in white blood cells, decrease in blood platelets which can lead to unusual bruising or easy bleeding (damage to red blood cells), increased blood sugar level (hyperglycaemia), a nerve disorder which can make you feel weak, decreased sensitivity to touch or tingling, cough, Swelling of the gums, bloated stomach (gastritis), abnormal liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice), increase in liver enzymes which can affect certain medical tests, increased muscle tension, inflammatory reactions in the blood vessels, often with a rash , Photosensitivity, disorders composed of stiffness, tremors and / or movement disorders.

4.2 What countermeasures should be taken if side effects occur?

Let your doctor know if you experience any side effects. He will decide on possible measures.

If you have a sudden or severe side effect, inform a doctor immediately, as certain drug side effects (e.g. excessive drop in blood pressure, hypersensitivity reactions) can have serious consequences under certain circumstances. In such cases, do not continue to take the medicine without doctor's advice.

Tell your doctor or pharmacist if you notice any side effects not listed here or in the package insert.

5. How should Amlodipine (besilat) Dexcel 5mg tablets be stored?

Store drug out of reach of children.

Do not use the medicine after the expiry date which is stated on the carton after "EXP" or "EXP". The expiry date refers to the last day of the month.

Do not store above 25ÂșC.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer need. This measure helps to protect the environment.

6. Source and processing status

Information from the SCHOLZ database based on the data approved by the Federal Office for Drugs and Medical Devices

Copyright by ePrax GmbH, Munich; December 2013 (3)