5 mg and 10 mg tablets
amlodipine
Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.
Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.

If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet:

  1. What Amlodipine Teva is and what it is used for
  2. What you need to know before you use Amlodipine Teva
  3. How to use Amlodipine Teva
  4. Possible side effects
  5. How to store Amlodipine Teva
  6. Package contents and other information
  7. What Amlodipine Teva is and what it is used for

Amlodipine Teva contains the active substance amlodipine which belongs to a group of medicines called calcium channel blockers.

Amlodipine Teva is used to treat high blood pressure ( hypertension ) or a special type of chest pain called angina. A rare form of this is Prinzmetal’s angina or variant angina.

In patients with high blood pressure, the drug reduces the resistance in the blood vessels, so that the blood can pass more easily.

In patients with angina, Amlodipine Teva works by increasing blood flow to the heart muscle, which then receives more oxygen. That way, chest pain is prevented. The drug does not provide immediate relief of chest pain in angina.

Amlodipine contained in Amlodipine Teva may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

  1. What you need to know before using Amlodipine Teva
    Do not use Amlodipine Teva
    if you are allergic to amlodipine or any of the other ingredients of this medicine (listed in section 6), or to any other calcium channel blocker. Symptoms may include 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 (aortic stenosis), or cardiogenic shock (a condition in which the heart is unable to supply the body with sufficient amounts of blood).

if you have heart failure after a heart attack.

Warnings and cautions
Talk to your doctor or pharmacist before using Amlodipine Teva.

Tell your doctor if you have or have had any of the following:

recent heart attack

heart failure

very high blood pressure (hypertensive crisis)

liver disease

if you are older and your dose needs to be increased

Children and young people
Amlodipine Teva has not been studied in children under 6 years of age. Amlodipine Teva should only be used to treat hypertension in children and adolescents aged 6 to 17 years (see section 3).
For more information, talk to your doctor.

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

Amlodipine Teva can affect or be affected by other medicines, such as:

ketoconazole and itraconazole ( antifungals )

ritonavir, indinavir, nelfinavir (so-called protease inhibitors used to treat HIV )

rifampicin, erythromycin, clarithromycin ( antibiotics for infection caused by bacteria)

Hypericum perforatum ( St. John’s wort )

verapamil, diltiazem (heart medicine)

dantrolene ( infusion for severe disorders of body temperature)

tacrolimus, sirolimus, temsirolimus, and everolimus (medicines used to change the way the immune system works)

simvastatin (a cholesterol-lowering drug)

ciclosporin (medicines that suppress the immune system)

Amlodipine Teva may lower your blood pressure further if you are already taking other medicines for high blood pressure.

Amlodipine Teva with food and drink
If you are taking Amlodipine Teva, do not eat grapefruit or drink grapefruit juice. Grapefruit and grapefruit juice can in fact lead to an increase in the amount of the active substance amlodipine in the blood, which can lead to an unpredictable increase in the blood pressure-lowering effect of Amlodipine Teva.

Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

The safety of amlodipine during pregnancy has not been established. If you think you are pregnant or planning to become pregnant, tell your doctor before using Amlodipine Teva.

Breast-feeding
Amlodipine passes into breast milk in small amounts. If you are breast-feeding or about to start breast-feeding, tell your doctor before using Amlodipine Teva.

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

Driving and using machines
Amlodipine Teva may affect your ability to drive or use machines. If you feel unwell, dizzy, or tired, or have headaches from the tablets, do not drive or use machines. Contact your doctor immediately.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Amlodipine Teva contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, ie essentially ‘sodium-free’.

How to use Amlodipine Teva
Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

The recommended starting dose is one Amlodipine Teva 5 mg tablet once daily. Dose one can be increased to an Amlodipine Teva 10 mg tablet once daily.

You can take the medicine before or after food or drink. You should take the medicine at the same time each day. Swallow the tablet immediately with a glass of water. Do not take Amlodipine Teva with grapefruit juice.

Use for children and adolescents
The recommended starting dose for children and adolescents (6‑17 years) is usually 2.5 mg daily. The maximum recommended dose is 5 mg daily.

Amlodipine Teva 5 mg tablet can be divided into two equal doses to obtain a dose of 2.5 mg.

Amlodipine Teva 10 mg tablets can also be divided into two equal doses.

If you have been told by your doctor to take ½ (half) tablets daily, we suggest that you do not use any tool to halve the tablet. See the following instructions for sharing the tablet:

Place the tablet on a flat, hard surface (such as a table or countertop), with the text facing up. Divide the tablet by pressing it with the index fingers placed along with the notch.

Divide the Amlodipine Teva tablet

If you use more Amlodipine Teva than you should
If you take too many tablets, your blood pressure may be low or even dangerously low. You may feel dizzy, unsteady, faint, or weak. If the blood pressure drops low enough, you can experience shock. The skin then feels cold and moist and you can become unconscious. Seek immediate care if you have taken too many Amlodipine Teva tablets.

If you forget to use Amlodipine Teva
Do not worry. If you forget to take a tablet, just ignore that dose. Take the next dose at the right time. Do not take a double dose to make up for a forgotten dose.

If you stop using Amlodipine Teva
Your doctor will tell you how long to take the medicine. Your illness may return if you stop taking the medicine earlier.

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

  1. Possible side effects
    Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking the medicine immediately and/or contact a doctor immediately if you get any of the following side effects 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 makes it very difficult to breathe

severe skin reactions such as severe rash, hives, redness all over the body, severe itching, blistering, skin flaking and swelling, inflamed mucous membranes ( Stevens-Johnson syndrome, toxic epidermal necrolysis ), or other allergic reactions

heart attack, abnormal heart rate

inflammation of the pancreas, which can cause severe abdominal and back pain and a strong feeling of illness.

The following very common side effects are reported. If any of these cause you problems or if they last for more than a week, consult your doctor.

Very common side effects: (may affect more than 1 user in 10)

edema (swelling due to fluid)

The following common side effects are reported. If any of these cause you problems or if they last for 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 (you feel the heartbeat), hot flashes

abdominal pain, nausea

altered bowel habits, diarrhea, constipation, indigestion

fatigue, weakness

visual disturbances, double vision

muscle cramps

swollen ankles

Other side effects reported are listed below. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Uncommon : (may affect up to 1 in 100 people)

mood swings, anxiety, depression, insomnia

tremors, taste change, fainting,

numbness or tingling in the arms and legs, inability to feel pain

earrings

low blood pressure

sneezing / runny nose due to inflammation of the nasal mucosa ( rhinitis )

cough

dry mouth, vomiting

hair loss, increased sweating, itchy skin, red spots on the skin, skin discoloration

urination problems, increased need to urinate at night, increased urination frequency

impotence, discomfort from or enlarged breasts in men

pain, feeling sick

joint or muscle 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 )

decreased number of white blood cells, decreased number of platelets that can lead to bruising or bleeding easily

elevated blood sugar (hyperglycemia)

a nerve disorder that can cause muscular weakness, tingling, or numbness

swollen gums

swollen abdomen ( gastritis )

abnormal liver function, inflammation of the liver ( hepatitis ), yellowing of the skin (jaundice), elevated liver enzymes that may affect certain medical tests

increased muscle tone (muscle tension)

inflammation of the blood vessels, often with a rash

photosensitivity.

Has been reported: (occurs in an unknown number of users)

tremors, stiff posture, worm-like face, slow movements, and sluggish, unbalanced gait.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. Postal address

  1. How to store Amlodipine Teva
    Keep this medicine out of the sight and reach of children.

Do not store above 25 ° C. Store in the original package. Sensitive to light. Moisture sensitive.

Do not use this medicine after the expiry date which is stated on the carton after EXP. date.or EXP. The expiration date is the last day of the specified month. Do not use this medicine if there are signs of discoloration or deterioration of the tablets.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

  1. Contents of the packaging and other information
    Content declaration
    The active substance is amlodipine (as besylate).

Amlodipine Teva 5 mg tablets

Each tablet contains amlodipine besylate equivalent to 5 mg amlodipine.

Amlodipine Teva 10 mg tablets

each tablet contains amlodipine besylate equivalent to 10 mg amlodipine.

The other ingredients are microcrystalline cellulose, calcium hydrogen phosphate, sodium starch glycolate, and magnesium stearate.

What the medicine looks like and the contents of the pack
Amlodipine Teva 5 mg tablets are white, round tablets, diameter 8 mm. One side is slightly concave with a break notch and embossed with A5. The other side is slightly arched and without markings.

Pack sizes: 15, 20, 28, 30, 30 (3×10), 50, 56, 84, 90, 98, 100, 112, 120, 200, 250 and 300 (10 x 30) tablets.

Calendar packaging: 28 tablets

Hospital packaging: 50 tablets

Plastic jars: 30, 98, 100, 200, and 250 tablets with a sealed, unscrewable lid.

Amlodipine Teva 10 mg tablets are white, round tablets, diameter 11 mm. One side is slightly concave with a break notch and embossed with A10. The other side is slightly arched and without markings.

Pack sizes: 14, 15, 20, 28, 30, 30 (3×10), 50, 56, 84, 90, 98, 100, 112, 120, 200 and 250 tablets.

Calendar packaging: 28 tablets

Hospital packaging: 50 tablets

Plastic jars: 30, 98, 100, 200, and 250 tablets with a sealed, unscrewable lid.

Not all pack sizes may be marketed.

Muhammad Nadeem

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