60 mg prolonged-release tablet is
isosorbide mononitrate

What Is Astosex Isosorbide Mononitrate is and what it is used for

Isosorbide mononitrate Astimex 60 mg prolonged-release tablets (hereinafter referred to as Isosorbide mononitrate Astimex in this leaflet) contain the active substance isosorbide mononitrate. It belongs to the group of medicines called nitrates.

  • It is used to prevent chest pain / angina (angina). Anxiety is an oppressive pain or a feeling of pressure over the chest, but the pain can also be felt in the neck or arm. The pain occurs when the heart muscle does not get enough oxygen to be able to pump around the blood.
  • It works by causing the blood vessels to relax and dilate. This makes it easier for the heart to pump around the blood in the body, which improves the flow of blood and oxygen to the heart muscle.

The tablets are made so that the drug is released slowly over several hours.

Isosorbide mononitrate contained in Isosorbide mononitrate Astimex may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before taking Astosex Isosorbide Mononitrate

DO NOT use these tablets to treat sudden chest pain (acute angina). Instead, seek medical attention immediately. These tablets act too slowly to treat this and are used only to prevent angina symptoms.

Do not use Isosorbide Mononitrate Astimex:

  • if you are allergic to isosorbide mononitrate or any of the other ingredients of this medicine (listed in section 6).
  • if you have ever had a stroke .
  • if you have very low blood pressure.
  • if you have severe anemia.
  • if you have heart problems called “cardiomyopathy” or “pericarditis” or have narrow heart valves.
  • if you are taking sildenafil or a similar medicine called phosphodiesterase type 5 inhibitor (used in male impotence). See section “Other medicines and Isosorbide mononitrate Astimex”.

Isosorbide mononitrate should not be used in patients with acute myocardial infarction with low filling pressure, head injury, cerebral haemorrhage, severe hypotension, or low blood volume.

Do not take Astosex Isosorbide Mononitrate if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking this medicine.

Warnings and cautions

Talk to your doctor or pharmacist before taking Astimex Isosorbide Mononitrate:

  • if you have impaired thyroid function.
  • if you have hypoxemia (low oxygen content in the blood, eg due to a lung disease).
  • if you have hypothermia (symptoms are chills, unusual sleepiness, confusion).
  • if you are malnourished.
  • if you have severe liver or kidney disease.

Other medicines and Isosorbide mononitrate Astimex

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes over-the-counter medicines and herbal medicines. This is because Astosex Isosorbide Mononitrate may affect the way other medicines work and other Astimex Isosorbide Mononitrate may affect.

Do not take Isime sorbid mononitrate Astimex if you are taking any of the following medicines:

  • Sildenafil or similar medicines called phosphodiesterase type 5 inhibitors (used in male impotence)

If you are taking any of these medicines for erectile dysfunction, concomitant use of nitrate medicines such as Isosorbide mononitrate Astimex may cause a severe and potentially dangerous drop in blood pressure. This can lead to fainting or, in the worst case, a heart attack.

The following medicines may affect the effect of Astosex Isosorbide Mononitrate:

  • norepinephrine (used to treat severe and severe hypotension)
  • acetylcholine (used to reduce pupil one during cataract surgery and other eye surgeries)
  • histamine (mainly used to diagnose certain diseases)
  • all blood pressure medications (eg beta blockers, calcium channel blockers, vasodilators , angiotensin II receptor antagonists, ACE inhibitors).

Isosorbide mononitrate Astimex with alcohol

Avoid drinking alcohol while taking Isosorbide mononitrate Astimex, as the side effect of low blood pressure may be worse than usual and you may feel dizzy or faint.

Pregnancy, breastfeeding and fertility

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

Driving and using machines

You may have a headache or feel dizzy after taking Astosex Isosorbide Mononitrate. If so, do not drive or use any tools or machines.

You are always responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharp 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.

Isosorbide mononitrate Astimex contains lactose and sucrose.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Astimex Isosorbide Mononitrate

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

How to take the medicine

  • The tablets can be divided into two equal doses.
  • Take the tablets with half a glass of water.
  • Do not crush or chew the tablets.

How much to take

  • The recommended dose is one or two Isosorbide Mononitrate Astimex 60 mg per day.
  • Take the medicine in the morning.
  • Your doctor may prescribe you a lower starting dose to avoid the side effects of treatment with Isosorbide mononitrate Astimex. Your dose can be from half a tablet (30 mg) up to two tablets (120 mg) per day.

Do not take Astimex Isosorbide Mononitrate in case of a sudden angina attack. If you have a sudden attack, take a tablet of glyceryl trinitrate (follow the instructions on the label).

Use for children

Do not give these tablets to children.

Use for the elderly

If you are older, your dose should be the same as above, except if you have low blood pressure or severe liver or kidney disease – you should always follow your doctor’s instructions.

If you are already taking medicines such as beta-blockers or calcium channel blockers, tell your doctor or pharmacist, as your doctor may need to adjust your dose of Isosorbide mononitrate Astimex or your other treatment (see section 2 “What you need to know before taking Isosorbide mononitrate Astimex”).

If you take more Isomezoride mononitrate Astimex than you should

If you have ingested too much medicine or if e.g. If a child has accidentally ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice. If you go to the hospital, bring the medicine pack so that the tablets can be identified.

Symptoms of overdose may include:

Throbbing headaches, agitation, cold sweats, nausea, vomiting, dizziness, fainting, and palpitations.

If you forget to take Isosorbide mononitrate Astimex

  • If you miss a dose , take it as soon as you remember. But if it’s almost time for your next dose, skip the missed dose .
  • Do not take a double dose to make up for a forgotten tablet.

If you stop taking Isime sorbid mononitrate Astimex

Do not suddenly stop taking Isosorbide Mononitrate Astimex tablets as this may make your angina worse. If your treatment is to be stopped, this should be done gradually. Be sure to follow your doctor’s instructions. If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

Headaches can occur when treatment is started but usually disappear after 1-2 weeks of treatment.

Low blood pressure with symptoms such as dizziness and nausea with dizziness in isolated cases has been reported occasionally. These symptoms usually disappear with continued treatment.

Other possible side effects:

Common (may affect up to 1 in 10 people)

  • Low blood pressure. This can make you feel weak or dizzy.
  • Increased heart rate .
  • Headache
  • Dizziness
  • Nausea

Uncommon (may affect up to 1 in 100 people)

Rare (may affect up to 1 in 1,000 people)

Very rare (may affect up to 1 in 10,000 people)

  • Muscle pain

Reporting of side effects

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. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.

5. How to store Isosorbide mononitrate Astimex

  • Keep this medicine out of the sight and reach of children
  • Do not store above 25 ° C
  • Do not use this medicine after the expiry date which is stated on the carton. 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 pack and other information

Content declaration

  • The active substance is isosorbide mononitrate. Each tablet contains 60 mg of the active substance.
  • The other ingredients are hydroxypropyl methylcellulose 2208, lactose , sucrose, maltodextrin, magnesium stearate, silica colloidal anhydrous, iron oxide yellow (E ‑ 172).

What the medicine looks like and contents of the pack

Isosorbide mononitrate Astimex tablets are light yellow biconvex, oval, with a scoreline on both sides and marked “DX 31” on one side.

Isosorbide mononitrate Astimex is available in blister packs containing 28, 30, or 98 tablets. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Dexcel Pharma GmbH

Carl-Zeiss-Straße 2

63755 Alzenau,

Germany

Manufacturer  and agent: 

Astimex pharma AB 

Isafjordsgatan 36

164 40 Kista

Muhammad Nadeem

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