AMLODIPINE MABO 10 mg TABLETS

2. What you need to know before you take Amlodipine Mabo

Do not take Amlodipine Mabo

• If you are allergic to amlodipine or any of the other ingredients of this medicine (listed in section 6), or to other calcium antagonists. This may be itching, redness of the skin, or difficulty breathing.
• If you have very low blood pressure (hypotension).
• If you have a narrowing of the aortic valve in your heart (aortic stenosis) or cardiogenic shock (a condition where the heart is unable to supply enough blood to the body).
• If you have heart failure after a heart attack.

Warnings and precautions

Talk to your doctor or pharmacist before taking Amlodipine Mabo. You should tell your doctor if you have or have had any of the following conditions:

• Recent heart attack.
• Heart failure.
• High blood pressure (hypertensive crisis).
• Liver disease.
• You are elderly and need to increase the dose.

Children and adolescents

Amlodipine has not been studied in children under 6 years old. Amlodipine Mabo should only be used to treat high blood pressure in children and adolescents from 6 to 17 years old (see section 3). For more information, talk to your doctor.

Other medicines and Amlodipine Mabo

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

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

• Ketoconazole and itraconazole (antifungal medicines).
• Ritonavir, indinavir, nelfinavir (protease inhibitors used to treat HIV).
• Rifampicin, erythromycin, clarithromycin (antibiotics for bacterial infections).
• Hypericum perforatum (St. John's Wort).
• Verapamil, diltiazem (heart medicines).
• Dantrolene (in infusion for severe body temperature anomalies).
• Tacrolimus, sirolimus, temsirolimus, and everolimus (medicines used to modify the functioning of your immune system).
• Simvastatin (a medicine to lower cholesterol).
• Ciclosporin (an immunosuppressant).

Amlodipine Mabo may lower your blood pressure even further if you are already taking other medicines to treat high blood pressure.

Taking Amlodipine Mabo with food and drinks

People taking Amlodipine should not take grapefruit juice or grapefruit. This is because grapefruit and grapefruit juice can lead to an increase in blood levels of amlodipine, which can cause an unpredictable increase in the blood-pressure-lowering effect of Amlodipine.

Pregnancy and breastfeeding

Pregnancy

The safety of amlodipine during pregnancy has not been established. If you are pregnant, think you may be pregnant, or plan to become pregnant, talk to your doctor before using Amlodipine.

Breastfeeding

Amlodipine has been shown to pass into breast milk in small amounts. If you are breastfeeding or about to start breastfeeding, talk to your doctor before taking Amlodipine.

Talk to your doctor or pharmacist before taking any medicine.

Driving and using machines

Amlodipine Mabo 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 talk to your doctor immediately.

3. How to take Amlodipine Mabo

Follow exactly the instructions of administration of this medicine given by your doctor or pharmacist. If you are unsure, talk to your doctor or pharmacist again.

The recommended initial dose is one 5 mg tablet of Amlodipine once a day. The dose can be increased to one 10 mg tablet of Amlodipine once a day.

This medicine can be taken before or after food and drinks. You should take your medicine every day at the same time with a glass of water. Swallow the tablet immediately with a glass of water. Do not take Amlodipine with grapefruit juice.

Use in children and adolescents

For children and adolescents (6-17 years) the recommended initial dose is 2.5 mg once daily.

The maximum recommended dose is 5 mg once daily.

It is important to keep taking the tablets. Do not wait until you have run out of tablets before going to see your doctor.

If you take more Amlodipine Mabo than you should

Taking too many tablets can cause your blood pressure to be too low or even dangerously low. You may feel dizzy, faint, or experience low blood pressure when standing up, or weakness. Severe low blood pressure can lead to shock. You may feel your skin cold and sweaty and lose consciousness. Seek immediate medical attention if you take too much Amlodipine.

Excess fluid can accumulate in the lungs (pulmonary edema) causing difficulty breathing, which can develop up to 24-48 hours after ingestion.

If you have taken too much Amlodipine Mabo, contact your doctor, an emergency service, or the Toxicology Information Service (telephone: 91.562.04.20), stating the medicine and the amount taken.

If you forget to take Amlodipine Mabo

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

If you stop taking Amlodipine Mabo

Your doctor will tell you for how long you should take this medicine. If you stop taking this medicine before, your symptoms may come back.

If you have any other questions about 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.

If you experience any of the following side effects after taking this medicine, talk to your doctor immediately.

• Sudden wheezing, chest pain, shortness of breath, or difficulty breathing.
• Swelling of the eyelids, face, or lips.
• Swelling of the tongue and throat, causing great difficulty breathing.
• Severe skin reactions, including intense skin rash, hives, redness of the skin all over the body, intense itching, blisters, peeling, and swelling of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis, or other allergic reactions).
• Heart attack, abnormal heart rhythms.
• Pancreatitis, which can cause severe abdominal and back pain, accompanied by a feeling of discomfort.

The following very common side effectshave been reported. If any of these cause you problems or last more than a week, you should talk to your doctor.

Very common: may affect more than 1 in 10 people

• Edema (fluid retention).

The following common side effectshave been reported. If any of these cause you problems or last more than a week, you should talk to your doctor.

Common: may affect up to 1 in 10 people

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

Other side effects have been reported, including those listed below. If any of these are severe or if you notice any side effects not mentioned in this leaflet, talk to your doctor or pharmacist.

Uncommon: may affect up to 1 in 100 people

• Mood changes, anxiety, depression, insomnia.
• Tremors, taste disturbances, fainting.
• Numbness or tingling in the limbs; loss of pain sensation.
• Ringing in the ears.
• Low blood pressure.
• Sneezing/nasal congestion caused by inflammation of the nasal mucosa (rhinitis).
• Cough.
• Dry mouth, vomiting (nausea).
• Hair loss, increased sweating, itching, red spots on the skin, skin discoloration.
• Urinary disorders, increased need to urinate during the night, increased frequency of urination.
• Impotence, breast pain or enlargement in men.
• Pain, feeling unwell.
• Joint or muscle pain, back pain.
• Weight gain or loss.

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

• Confusion.

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

• Decrease in white blood cell count, decrease in blood platelets, which can cause unusual bleeding or bruising.
• High blood sugar (hyperglycemia).
• Nerve disorders, which can cause muscle weakness, tingling, or numbness.
• Gingivitis.
• Abdominal distension (gastritis).
• Abnormal liver function, liver inflammation (hepatitis), yellowing of the skin (jaundice), increased liver enzymes, which may affect some medical tests.
• Increased muscle tension.
• Inflammation of blood vessels, often with skin rashes.
• Sensitivity to light.
• Disorders combining stiffness, tremor, and/or movement disorders.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) via their website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Amlodipine Mabo

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 blister and carton after EXP. The expiry date refers to the last day of the month shown.

Store below 25°C.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help to protect the environment.

6. Contents of the pack and other information

Composition of Amlodipine Mabo

• The active substance is amlodipine (as besylate). Each tablet contains amlodipine besylate equivalent to 10 mg of amlodipine.
• The other ingredients are calcium hydrogen phosphate dihydrate, magnesium stearate, microcrystalline cellulose, anhydrous colloidal silica, and sodium starch glycolate (Type A).

Appearance and packaging

White to off-white, round (10.5 mm – 10.7 mm), biconvex tablets, marked with “10” on one face.

Amlodipine Mabo 10 mg tablets are available in PVC-PVDC/Aluminum blisters containing 30 tablets.

Marketing authorization holder

MABO-FARMA S.A.

Vía de los Poblados, 3,

Edificio 6, 28033 Madrid,

Spain.

Manufacturer

PharmaS d.o.o.

Industrijska cesta 5

44317 Potok, Popovaca

Croatia

Date of last revision of this leaflet: July 2022

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es

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