AMLODIPINE ALMUS 5 mg TABLETS

Introduction

Package Leaflet: Information for the User

Amlodipine Almus 5 mg Tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

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

1. What is Amlodipine Almus and what is it 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, which includes a rare type called Prinzmetal's or variant angina.

In patients with high blood pressure, this medicine works by relaxing blood vessels, so that blood passes through them more easily. In patients with angina, Amlodipine Almus improves blood supply to the heart muscle, which receives more oxygen and as a result, the pain in the chest is prevented. This medicine does not provide immediate relief of chest pain due to angina.

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

Do not take Amlodipine Almus

• If you are allergic (hypersensitive) to amlodipine or 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 (aortic stenosis) or cardiogenic shock (a disease in which the heart is unable to pump enough blood to the body).
• If you have heart failure after a heart attack.

Warnings and precautions

Consult 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 diseases:

• Recent heart attack

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

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 from 6 to 17 years of age (see section 3).

For more information, consult your doctor.

Using Amlodipine Almus with other medicines

Tell your doctor or pharmacist if you are using or have recently used other medicines, even 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 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)
• tacrolimus, sirolimus, temsirolimus, and everolimus (medicines used to modify the functioning of the immune system)
• simvastatin (a medicine that lowers cholesterol)
• ciclosporin (immunosuppressant)

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

Taking Amlodipine Almus with food and drinks

People taking Amlodipine Almus 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 Almus.

Pregnancy and breastfeeding

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 Almus.

Breastfeeding

Amlodipine has been shown to pass 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 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.

Amlodipine Almus 5 mg tabletscontainlactose and sodium

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is, essentially "sodium-free".

3. How to take Amlodipine Almus

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The usual initial dose is 5 mg of amlodipine once a day. The dose can be increased to 10 mg of amlodipine, 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 this medicine with grapefruit juice.

Use in children and adolescents

For children and adolescents (between 6-17 years of age), the recommended initial dose is usually 2.5 mg per day. The maximum recommended dose is 5 mg per day. The tablet can be divided into equal doses to provide a 2.5 mg dose.

It is important not to interrupt the administration of the tablets. Do not wait until the tablets are finished to go to your doctor.

If you take more Amlodipine Almus than you should

Taking too many tablets can cause a drop in blood pressure or even a dangerous drop. You may feel dizzy, faint, suffer from 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 wet and could lose consciousness. If you take too many tablets of this medicine, consult your doctor immediately or call the Toxicology Information Service, telephone 91 562 04 20.

Excess fluid may accumulate in the lungs (pulmonary edema) causing difficulty breathing, which can develop up to 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 forgotten dose.

If you stop taking Amlodipine Almus

Your doctor will indicate how long you should take this medicine. Your disease may recur if you stop taking this medicine before your doctor indicates.

If you have any other 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 everybody gets them.

Go to your doctor immediately if you experience any of the following serious side 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 that causes great difficulty breathing
• Severe skin reactions, including intense skin rash, hives, skin redness all over the body, intense 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 that can cause severe abdominal pain and back pain accompanied by a great feeling of discomfort

The following very common side effect has been reported. If this causes problems or lasts more than a week, consult your doctor.

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

• Edema (fluid retention)

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

Common(may affect up to 1 in 10 people)

• Headache, dizziness, drowsiness (especially at the beginning of treatment)
• Palpitations (feeling the heartbeat), flushing
• Abdominal pain, feeling unwell (nausea)
• Change in bowel habit, diarrhea, constipation, indigestion
• Fatigue, weakness
• Visual disturbances, double vision
• Muscle cramps
• Swelling of the ankles

The following other side effects have been reported, which are included in the following list. If you think any of the side effects you are suffering from is serious, or if you notice any side 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
• Tremors, taste disturbances, fainting
• Numbness or tingling in the limbs, loss of pain sensation
• Ringing in the ears
• Decrease in blood pressure
• Sneezing/nasal secretion 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
• Urination disorder, increased need to urinate at night, increased number of times urinating
• Impotence, discomfort or breast enlargement in men
• Pain, feeling unwell
• Pain in the muscles or joints, 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 the number of white blood cells, decrease in blood platelets that can cause easy bleeding or unusual bruising
• High blood sugar (hyperglycemia)
• A disorder of the nerves that can cause muscle weakness, tingling, or numbness
• Gingivitis, gum bleeding
• Abdominal swelling (gastritis)

• Abnormal liver function, liver inflammation (hepatitis), yellowing of the skin (jaundice), increased liver enzymes that can affect some medical tests
• Increased muscle tone
• Inflammation of blood vessels, often with skin rashes
• Sensitivity to light
• Disorders combining stiffness, tremors, and/or movement disorders

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

• Tremors, rigid posture, mask-like face, slow and unsteady gait

Reporting of side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if it is a side effect not mentioned in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines. Website: ww.notificaram.es.

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

5. Storage of Amlodipine Almus

Keep out of the sight and reach of children.

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

Do not store above 25°C.

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

6. Contents of the pack and further information

Composition ofAmlodipine Almus

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

• The other ingredients are: sodium carboxymethyl starch (potato), microcrystalline cellulose E 460i, lactose monohydrate, magnesium stearate E 470b. See section 2Amlodipine Almus 5 mg tablets contain lactose and sodium.

Appearance of Amlodipine Almus and contents of the pack

White, round, flat tablets with a score line on one side.

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

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Almus Pharmaceutical, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Telephone: 93 739 71 80

Email: farmacovigilancia@almusfarmaceutica.es

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 last revision of this leaflet: May 2024

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