Amlodipine Almus 10 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Amlodipine Almus 10 mg tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as 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, and you should not give it to other people even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if these are effects not listed in this leaflet. See section 4.

Leaflet contents:

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

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

Amlodipine Almus contains the active substance amlodipine, which belongs to a group of medicines known as calcium antagonists.

Amlodipine Almus is used to treat high blood pressure (hypertension) or a certain type of chest pain called angina, including a less common type known as Prinzmetal's angina or variant angina.

In patients with high blood pressure, this medicine works by relaxing the blood vessels, allowing blood to pass through them more easily. In patients with angina, Amlodipine Almus improves blood flow to the heart muscle, thereby supplying it with more oxygen and preventing chest pain. This medicine does not provide immediate relief of angina-related chest pain.

2. What you need to know before taking Amlodipine Almus

Do not take Amlodipine Almus

• 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. 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 in the heart (aortic stenosis) or cardiogenic shock (a condition in which the heart is unable to pump enough blood to the body).
• If you have heart failure following a heart attack.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Amlodipine Almus.

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 may need adjustment

Children and adolescents

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

For further information, consult your doctor.

Taking Amlodipine Almus with other medicines

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

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

• ketoconazole, itraconazole (antifungal medicines)
• ritonavir, indinavir, nelfinavir (also known as protease inhibitors used to treat AIDS)
• rifampicin, erythromycin, clarithromycin (antibiotics)
• Hypericum perforatum (St. John's Wort)
• verapamil, diltiazem (heart medicines)
• dantrolene (intravenous infusion for serious disturbances in body temperature)
• tacrolimus, sirolimus, temsirolimus, and everolimus (medicines used to modify the function of the immune system)
• simvastatin (a cholesterol-lowering medicine)
• ciclosporin (an immunosuppressant)

If you are already taking other medicines to treat high blood pressure, Amlodipine Almus may lower your blood pressure even further.

Taking Amlodipine Almus with food and drink

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

Pregnancy and breast-feeding

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 must inform your doctor before taking Amlodipine Almus.

Breast-feeding

It has been shown that amlodipine passes into breast milk in small amounts. If you are breastfeeding or about to start breastfeeding, you should inform your doctor before taking Amlodipine Almus.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

Amlodipine Almus may affect your ability to drive or operate machinery. If the tablets make you feel unwell, dizzy, tired, or cause you to have a headache, do not drive or operate machinery and consult your doctor immediately.

Amlodipine Almus 10 mg tablets contain lactose and sodium

If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; essentially “sodium-free”.

3. How to take Amlodipine Almus

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The usual starting dose is 5 mg of amlodipine once daily. The dose may be increased to 10 mg of amlodipine once daily.

You may take this medicine before or after meals. Take it at the same time each day with a glass of water. Do not take amlodipine with grapefruit juice.

Use in children and adolescents

For children and adolescents (aged 6–17 years), the usual recommended starting dose is normally 2.5 mg daily. The maximum recommended dose is 5 mg daily.

An Amlodipine Almus 5 mg tablet is available which can be divided into equal doses to provide 2.5 mg doses.

It is important not to interrupt administration of the tablets. Do not wait until you run out of tablets before seeing your doctor.

If you take more Amlodipine Almus than you should

Taking too many tablets may cause a drop in blood pressure or even a dangerous drop. You may feel dizzy, lightheaded, experience postural dizziness when standing up, or weakness. If the drop in blood pressure is severe enough, shock may occur. You may feel your skin cold and clammy and you could lose consciousness. If you take too many amlodipine tablets, contact your doctor immediately or call the Toxicology Information Service at telephone number 91 562 04 20.

Excess fluid may accumulate in the lungs (pulmonary edema), causing breathing difficulties, which may develop 24–48 hours after ingestion.

If you forget to take Amlodipine Almus

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 missed dose.

If you stop taking Amlodipine Almus

Your doctor will advise you on how long you should take this medicine. Your condition may recur if you stop taking this medicine before your doctor tells you to do so.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Contact your doctor immediately if you experience any of the following serious adverse effects, which are very rare after 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 severe difficulty in breathing
• Severe skin reactions including severe rash, hives, redness of the skin all over the body, intense itching, blistering, peeling and skin inflammation, inflammation of mucous membranes (Stevens-Johnson Syndrome, toxic epidermal necrolysis) or other allergic reactions
• Heart attack, irregular heartbeat
• Inflammation of the pancreas which may cause severe abdominal pain and back pain accompanied by a strong feeling of malaise

The following very common adverse effect has been reported. If this causes problems or lasts longer than one week, consult your doctor.

Very common (may affect more than 1 in 10 people):

• Edema (fluid retention)

The following common adverse effects have been reported. If any of these cause problems or last longer 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 heartbeat), hot flush
• Abdominal pain, feeling unwell (nausea)
• Changes in bowel habits, diarrhoea, constipation, indigestion
• Fatigue, weakness
• Visual disturbances, double vision
• Muscle cramps
• Swelling of ankles

Other adverse effects that have been reported are listed below. If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not mentioned 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
• Numbness or tingling sensation in the limbs, loss of pain sensation
• Ringing in the ears
• Decrease in blood pressure
• Sneezing/nasal discharge due to inflammation of the nasal mucosa (rhinitis)
• Cough
• Dry mouth, vomiting (feeling unwell)
• Hair loss, increased sweating, skin itching, red spots on the skin, skin discoloration
• Urinary disorders, increased need to urinate at night, increased frequency of urination
• Inability to achieve an erection, discomfort or enlargement of the breasts in men
• Pain, feeling unwell
• Muscle or joint 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):

• Decrease in white blood cells, decrease in blood platelets which may cause easy bleeding or unusual bruising

• High blood sugar (hyperglycaemia)

• A nerve disorder which may cause muscle weakness, tingling or numbness

• Inflammation of the gums, bleeding gums

• Abdominal swelling (gastritis)

• Liver function abnormalities, inflammation of the liver (hepatitis), yellowing of the skin (jaundice), increased liver enzymes which may affect certain medical tests

• Increased muscle tension

• Inflammation of blood vessels, often with skin rashes

• Light sensitivity

• Disorders combining rigidity, tremor and/or movement disorders

Frequency not known (cannot be estimated from available data):

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

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist or nurse, even if it is an adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products. Website: www.notificaram.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Amlodipine Almus

Keep out of 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 the month indicated.

Do not store above 25 °C.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point in your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Amlodipine Almus

The active substance in Amlodipine Almus 10 mg tablets is amlodipine (as besilate).

• Other components are: sodium carboxymethyl starch (from potato), microcrystalline cellulose E 460i, lactose monohydrate, magnesium stearate E 470b. See section 2 Amlodipine Almus 10 mg tablets contain lactose and sodium.

Appearance of Amlodipine Almus and contents of the pack

White, round, flat tablets, marked on one side.

The tablet can be divided into equal doses.

Amlodipine Almus 10 mg tablets are available in blister packs containing 30 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Telephone: 93 739 71 80

Email: [email protected]

Manufacturer

West Pharma - Producções de Especialidades Farmacêuticas, S.A.

Rua João de Deus, nº 11, Venda Nova.

2700 Amadora, Portugal

Atlantic Pharma - Produções Farmacêuticas, S.A.

Rua De Tapada Grande 2

Abrunheira, Sintra, 2710-228

Portugal

Date of the most recent review of this leaflet: May 2024

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