AMLODIPINE COMBIX 5 mg TABLETS

2. Before taking Amlodipine Combix

Do not take Amlodipine Combix

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

Be cautious with Amlodipine Combix

You should inform your doctor if you have or have had any of the following conditions:

• Recent heart attack
• Heart failure
• Severe increase in blood pressure (hypertensive crisis)
• Liver disease
• You are elderly and your dose needs to be increased

Use in children and adolescents

Amlodipine Combix has not been studied in children under 6 years of age. Amlodipine Combix should only be used to treat high blood pressure in children and adolescents from 6 to 17 years of age. (See section 3).

For more information, consult your doctor.

Using other medicines

Tell your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription.

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

• ketoconazole, itraconazole (antifungal medicines)
• ritonavir, indinavir, nelfinavir (also called protease inhibitors used to treat AIDS)
• rifampicin, erythromycin, clarithromycin (antibiotics)
• Hypericum perforatum (St. John's Wort)
• verapamil, diltiazem (heart medicines)
• dantrolene (in infusion for severe body temperature abnormalities)

If you are already taking other medicines for high blood pressure, Amlodipine Combix may lower your blood pressure even further.

Taking Amlodipine Combix with food and drinks

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

Pregnancy

The safety of amlodipine during pregnancy has not been established. If you think you may be pregnant or are planning to become pregnant, you should inform your doctor before taking Amlodipine Combix.

Breast-feeding

Amlodipine has been shown to pass into breast milk in small amounts. If you are breast-feeding or about to start breast-feeding, you should inform your doctor before taking Amlodipine Combix.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

Amlodipine Combix 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 machinery and consult your doctor immediately.

3. How to take Amlodipine Combix

Always take your medicine exactly as your doctor has told you. Consult your doctor or pharmacist if you are unsure.

The initial normal dose is 5 mg of Amlodipine Combix, once a day. The dose can be increased to 10 mg of Amlodipine Combix, once a day.

You can take your medicine before or after meals. You should take it at the same time each day, with a glass of water. Do not take Amlodipine Combix with grapefruit juice.

Use in children and adolescents

For children and adolescents (between 6-17 years of age), the recommended initial dose is 2.5 mg per day. The maximum recommended dose is 5 mg per day.

Amlodipine 2.5 mg is not currently available, and a dose of 2.5 mg cannot be obtained with Amlodipine Combix 5 mg tablets, as these tablets are not designed to be divided into equal parts.

It is essential not to interrupt the administration of the tablets. Do not wait until the tablets are finished before consulting your doctor.

If you take more Amlodipine Combix than you should

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

Taking too many tablets can cause a drop in blood pressure or even a dangerous drop. You may feel dizzy, faint, experience dizziness when standing up, or weakness. If the drop in blood pressure is severe, it can cause shock. You may feel your skin cold and sweaty, and you could lose consciousness. If you take too many Amlodipine Combix tablets, consult your doctor immediately or call the Toxicology Information Service, phone 91 562 04 20.

If you forget to take Amlodipine Combix

Do not worry. If you forget to take a tablet, do not take that dose. Take the next dose at the correct time. Do not take a double dose to make up for the forgotten dose.

If you stop taking Amlodipine Combix

Your doctor will tell you for how long you should take this medicine. Your condition may recur if you stop taking this medicine before your doctor tells you to.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Amlodipine Combix can cause side effects, although not everybody gets them.

See your doctor immediatelyif you experience any of the following serious side effects, which are very rare when taking this medicine.

• 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 rash, hives, redness of the skin all over the body, itching, blistering, peeling, and inflammation of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis), or other allergic reactions
• Heart attack, abnormal heartbeat
• Pancreatitis, which can cause severe abdominal pain and back pain, accompanied by a great feeling of discomfort

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

Common:affects between 1 and 10 in every 100 patients

• Headache, dizziness, drowsiness (especially at the start of treatment)
• Palpitations (feeling your heartbeat), flushing
• Abdominal pain, feeling sick (nausea)
• Swelling of the ankles (edema), tiredness

Other side effects have been reported, which are included in the following list. If you think any of the side effects you are experiencing is serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

Uncommon:affects between 1 and 10 in every 1,000 patients

• Mood changes, anxiety, depression, insomnia
• Tremor, taste disturbances, fainting, weakness
• Numbness or tingling in the limbs, loss of pain sensation
• Visual disturbances, double vision, ringing in the ears
• Low blood pressure
• Sneezing/nasal secretion caused by inflammation of the nasal mucosa (rhinitis)
• Changes in bowel habits, diarrhea, constipation, indigestion, dry mouth, vomiting (nausea)
• Hair loss, increased sweating, itching, red spots on the skin, skin discoloration
• Urination disorders, increased need to urinate at night, increased frequency of urination
• Impotence, discomfort or enlargement of the breasts in men
• Weakness, pain, feeling unwell
• Muscle or joint pain, muscle cramps, back pain
• Weight gain or loss

Rare:affects between 1 and 10 in every 10,000 patients

• Confusion

Very rare:affects less than 1 in every 10,000 patients

• Decrease in white blood cell count, decrease in blood platelets, which can cause easy bruising or bleeding (red blood cell damage)
• High blood sugar (hyperglycemia)
• A disorder of the nerves that can cause weakness, tingling, or numbness
• Cough, gum inflammation
• Abdominal swelling (gastritis)
• Abnormal liver function, liver inflammation (hepatitis), yellowing of the skin (jaundice), increased liver enzymes, which can 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 side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Amlodipine Combix

Keep out of the reach and sight of children.

Do not use this medicine after the expiry date stated on the packaging, after EXP. The expiry date is the last day of the month shown.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Further information

Composition of Amlodipine Combix

The active substance of Amlodipine Combix 5 mg tablets is amlodipine (as besylate).

• The other ingredients are microcrystalline cellulose (E460i), sodium starch glycolate (potato starch), anhydrous colloidal silica (E551), and magnesium stearate (E470b).

Appearance of Amlodipine Combix and packaging contents

White or almost white, round tablets, marked with "AM5" on one side and smooth on the other.

Amlodipine Combix 5 mg tablets are available in blister packs containing 30 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios Combix, S.L.U.

C/Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

Pharmex Advanced Laboratories, S.L.

Ctra. A-431 Km. 19

14720 Almodóvar del Río (Córdoba)

Spain

This leaflet was approved in July 2022

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