200 mg hard 
prolonged-release capsules Dipyridamole

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, pharmacist, or nurse.
  • 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, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Dipyridamole Alternova is and what it is used for 
2. What you need to know before you use Dipyridamole Alternova 
3. How to use Dipyridamole Alternova 
4. Possible side effects 
5. How to store Dipyridamol Alternova 6. Contents of the pack 
and other information 

1. What Dipyridamole Alternova is and what it is used for

You need to talk to a doctor if you do not feel better or if you feel worse after a few days.

Dipyridamole Alternova reduces the tendency of platelets to form blood clots.

Dipyridamole is used to prevent blood clots in the brain, or if you have had a stroke or if you have had temporary paralysis or disturbances of circulation to the brain (a stroke or transient ischemic attack – TIA ).

You can take the capsules together with other prophylactic drugs ( acetylsalicylic acid). If you cannot tolerate acetylsalicylic acid, you can only take Dipyridamole capsules.

Dipyridamole contained in Dipyridamole Alternova 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.

What you need to know before you use Dipyridamole Alternova

Do not use Dipyridamole Alternova

  • if you are allergic to dipyridamole or any of the other ingredients of this medicine (listed in section 6).

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before using Dipyridamole Alternova if you have:

  • a severe heart disease
  • myasthenia gravis (a rare muscle disease)

Tell your doctor that you are taking dipyridamole Alternova if you are going to have your heart function tested. Treatment with Dipyridamole Alternova may affect the results of the test. To get an accurate result of the test, you may need to take a break with Dipyridamol Alternova before performing the test.

Children

Dipyridamole Alternova is not recommended for use in children because of a lack of experience with dipyridamole in children.

Other medicines and Dipyridamole Alternova

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

Tell your doctor or pharmacist if you are taking medicines for:

  • myasthenia gravis (a muscle disease)
  • high blood pressure
  • irregular heartbeat (medicines containing adenosine ). Your dose can be adjusted.
  • asthma or COPD (eg theophylline and other xanthines)
  • other anticoagulants (eg warfarin, acetylsalicylic acid )

Dipyridamol Alternova with food, drink, and alcohol

Dipyridamole Alternova can be taken with a meal, but it can also be taken without food.

Pregnancy, breastfeeding, and fertility

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

You should not take Dipyridamole Alternova if you are pregnant unless your doctor thinks it is necessary. Consult a doctor.

Breast-feeding

If you are breast-feeding, do not take Dipyridamole Alternova as dipyridamole is excreted in human milk. Talk to your doctor.

Fertility

The effect of dipyridamole on human fertility has not been studied. Animal studies with dipyridamole showed no adverse effects on fertility.

Driving and using machines

Dipyridamole Alternova, due to side effects such as headache, dizziness, nausea, and vomiting, has a little or moderate effect on the ability to drive and use machines. If you experience these symptoms, do not drive or use machines.

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.

How to use Dipyridamole Alternova

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

Adults

The recommended dose is one capsule twice daily, usually morning and evening.

The capsules can be taken with or without food. The prolonged-release capsules should be swallowed whole without chewing.

Alternative dosage for intolerable headaches

If you experience severe headaches that you cannot tolerate at the beginning of treatment with Dipyridamol Alternova, you may need another dose. Talk to your doctor. 
Your doctor may tell you to take 1 capsule at bedtime and low-dose acetylsalicylic acid in the morning. Usually, the headache disappears with regular dosing, and therefore it is strongly recommended that you return to the usual dosing one within a week.

Use for children and adolescents

Dipyridamole Alternova is not recommended for use in children.

Older

No dose adjustment is required. Follow your doctor’s instructions.

Patients with renal impairment

No dose adjustment is required. Follow your doctor’s instructions.

Patients with hepatic impairment

No dose adjustment is required. Follow your doctor’s instructions.

If you use more Dipyridamole Alternova then you should 

If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

Symptoms of overdose such as hot flashes, hot flashes, sweating, agitation, and feeling of weakness, dizziness, and headache may occur if you take more Dipyridamole Alternova than you should. You may also experience a faster heart rate, rapid breathing, drop in blood pressure, chest pain, indigestion, difficulty breathing with bluish lips and nails, prolonged bleeding time, and yellowing of the skin. Unconsciousness has also occurred.

If you forget to take Dipyridamole Alternova

If you miss a dose, take it as soon as you remember. However, if it is time for the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.

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

4. Possible side effects

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

The most common side effects are nausea and headache. In most cases, these symptoms subside with continued treatment.

Serious side effects:

The following side effects are serious and may require immediate treatment. Contact your doctor or nearest emergency department as soon as possible.

Common (may affect up to 1 in 10 people):

  • Chest pain with possible radiation to the neck or arms and difficulty breathing ( Angina pectoris )

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

  • Fast pulse
  • A blood disorder called “thrombocytopenia” can cause bruising and prolonged bleeding from wounds
  • Increased bleeding during or after surgery
  • Allergic reactions (hypersensitivity) with pressure over the chest and difficulty breathing, skin rash and itching, swelling of the tongue, lips, and face
  • Gallstones with sudden and rapidly worsening pain in the middle of the abdomen or under the right sternum
  • Bronchospasm (difficulty breathing, asthma-like attacks)

Other side effects:

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

  • Nausea, headache, dizziness, diarrhea

Common (may affect up to 1 in 10 people):

  • Vomiting
  • Muscle pain
  • Rash

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

  • Dizziness or fainting due to lowering of blood pressure
  • Hot flashes
  • Hives ( urticaria )

Reporting of side effects ar

If you get any side effects, talk to your doctor, pharmacist,t or nurse. This also applies to side effects that are not mentioned in this information. You can also report side effects directly (see details below). By reporting side effects, you can help increase drug safety information.

The Medical Products Agency

Box 26

751 03 Uppsala

5. How to store Dipyridamol Alternova

Keep this medicine out of the sight and reach of children.

Store at a maximum of 30º C. Closes the jar tightly. Moisture sensitive.

Do not open the jar until you are ready to start taking the capsules. If you have capsules left after 6 weeks, do not take them.

Do not use this medicine after the expiry date which is stated on the carton and plastic container after EXP. The expiration date is the last day of the specified month.

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.

6. Contents of the packaging and other information

Content declaration

The active substance is dipyridamole.

The other ingredients are: 96% tartaric acid pellets (2% sucrose and 2% povidone K-30s); hypromellose E 15; talc; acacia, spray-dried; triacetin; povidone (PVP K30); simethicone emulsion contains: simethicone, macrogolcetostearyl ether, sodium benzoate, purified water; methacrylic acid-ethyl acrylate copolymer; hypromellose phthalate P55

Capsule shell: gelatin; titanium dioxide (E171); red and yellow iron oxide (E172)

What the medicine looks like and the contents of the pack

The prolonged-release capsules are hard gelatin capsules with a red upper part and an orange lower part dimensions 7.66 x 23.1 mm. The capsule contains yellow pellets with delayed-release.

Plastic jar containing a desiccant. The desiccant consists of a bag containing silica gel.

The package contains 30, 50, 60, 100 or 100 (2×50) capsules.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder:

Alternova A / S

Lodshusvej 11

4230 Skælskør

Denmark

Manufacturer:

Orifarm Generics A / S,

Energizer 15

5260 Odense S

Denmark


This medicinal product is authorized under the European Economic Area under the names:

Denmark: Dipyridamole Alternova 200 mg prolonged-release hard capsules

Norway: Aponova 200 mg prolonged-release capsules, hard

Muhammad Nadeem

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