12.5 mg film-coated tablets 
almotriptan

Read all of this leaflet carefully before you start taking 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 may harm them, even if they show symptoms 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 you will find information about: 
1. What Almotriptan Orifarm is and what it is used for 
2. What you need to know before you take Almotriptan Orifarm 
3. How to take Almotriptan Orifarm 
4. Possible side effects 
5. How to store Almotriptan Orifarm 
6. Contents of the packaging and other information 

What Almotriptan Orifarm is and what it is used for

Almotriptan Orifarm is a migraine medicine that belongs to a group of substances called selective serotonin receptor agonists. Almotriptan Orifarm is thought to reduce the inflammatory response associated with migraines by binding to the serotonin receptors in the brain’s (cranial) blood vessels and causing them to constrict.

Almotriptan Orifarm is used to relieve headaches associated with migraine attacks with or without aura.

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

What you need to know before you take Almotriptan Orifarm

Do not take Almotriptan Orifarm

  • if you are allergic to almotriptan or any of the other ingredients of this medicine (listed in section 6).
  • if you have or have had diseases that inhibit the blood supply to the heart, for example:
    • myocardial infarction
    • chest pain or discomfort that normally occurs during activity or stress
    • heart problems without pain 
    • chest pain at rest
    • severe hypertension (very high blood pressure )
    • uncontrolled mild or moderate high blood pressure.
  • if you have had a stroke or decreased blood flow to the brain
  • if you have had obstruction of the major arteries are in the arms or legs ( peripheral vascular disease)
  • if you are taking other medicines to treat migraines, e.g. ergotamine, dihydroergotamine, and methysergide, or other serotonin agonists (eg sumatriptan).
  • if you have severe liver disease.

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before taking Almotriptan Orifarm:

  • if you have not had your type of migraine diagnosed
  • if you are allergic (hypersensitive) to antibacterial drugs that are mainly used to treat urinary tract infections ( sulfonamides )
  • if your headache symptoms differ from your usual seizures, ie. if you hear a sound in your ears or have dizziness, you experience short-term paralysis of one side of the body or paralysis of the muscles that control eye movements or if you have any new symptoms
  • if you are at risk of heart disease, this includes uncontrolled high blood pressure, high cholesterol, obesity, diabetes, smoking, family heart disease, postmenopausal women or men over 40 years
  • if you have mild to moderate liver disease
  • if you have severe kidney disease.
  • if you are over 65 years of age (as you are more likely to have high blood pressure)
  • if you are taking antidepressant SSRIs (selective serotonin reuptake inhibitors) or SNRIs ( serotonin noradrenaline reuptake inhibitors). See also ‘Other medicines and Almotriptan Orifarm’ below.

There are signs that the excessive use of migraine medications can lead to daily chronic headaches.

Children and young people

Children under 18 years of age should not take Almotriptan Orifarm.

Elderly (over 65 years)

If you are over 65 years of age, talk to your doctor before taking this medicine.

Other medicines and Almotriptan Orifarm

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

Tell your doctor:

  • if you are taking medicines to treat depression, such as monoamine oxidase inhibitors (eg moclobemide), selective serotonin reuptake inhibitors (eg fluoxetine), or serotonin noradrenaline reuptake inhibitors (eg venlafaxine ), as these may lead to serotonergic syndrome; can be life-threatening. The symptoms of serotonin syndrome are confusion, restlessness, fever, sweating, uncoordinated movements of the arms and legs and eyes, uncontrolled muscle twitching, or diarrhea.
  • if you are taking the herbal medicine St. John’s wort (Hypericum perforatum) as it may increase the risk of side effects.

Almotriptan Orifarm should not be taken at the same time as ergotamine- containing medicines, which are also used to treat migraines. However, you can take the medicines one after the other, provided that there is some time between taking each medicine

  • After taking almotriptan, you should wait at least 6 hours before taking ergotamine.
  • After taking ergotamine, you should wait at least 24 hours before taking almotriptan.

Almotriptan Orifarm with food and drink

Almotriptan Orifarm tablets should be taken with liquid (eg water) and can be taken with or 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.

There is only very limited information on the treatment of pregnant women with almotriptan. You should only use Almotriptan Orifarm during pregnancy if your doctor has prescribed it after carefully considering the benefits and risks.

Caution should be exercised when using this medicine while breast-feeding. You should avoid breastfeeding for 24 hours after taking this medicine.

Driving and using machines

Almotriptan Orifarm may make you sleepy. If you suffer from this, do not drive or use any tools or machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. 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 take Almotriptan Orifarm

Only use Almotriptan Orifarm to treat an acute migraine attack and not to prevent migraine attacks or headaches.

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

The recommended dose is:

Adults (18-65 years)

The recommended dose is a 12.5 mg tablet, which should be taken as early as possible after the onset of the migraine attack. If the migraine attack does not subside, do not take more than one tablet during the same attack.

If you have a second migraine attack within 24 hours, you can take another 12.5 mg tablet, but there must be at least two hours between the first and second tablets.

The maximum daily dose is two (12.5 mg) tablets for 24 hours.

The tablets should be swallowed whole with liquid (eg water) and can be taken with or without food.

You should always take Almotriptan Orifarm as soon as possible after the onset of the migraine attack, although it is still effective if you take it later.

Severe kidney disease

If you have severe kidney disease, do not take more than 12.5 mg tablet per 24 hours.

Use for children and adolescents

Almotriptan Orifarm is not recommended for use in children and adolescents below 18 years.

If you forget to take Almotriptan Orifarm

Take Almotriptan Orifarm exactly as your doctor has told you. Do not take a double dose to make up for a forgotten tablet.

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.

During treatment with Almotriptan Orifarm, tell your doctor immediately:

  • if you experience chest pain, tightness in the chest or throat, or other symptoms reminiscent of a heart attack ( may affect up to 1 in 10,000 people ). Contact a doctor immediately and do not take any more Almotriptan Orifarm tablets.

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

  • dizziness
  • somnolence
  • nausea
  • vomiting
  • fatigue

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

  • creep, tingling, or numbness in the skin ( paresthesia )
  • headache
  • ringing, howling, or clicking sounds in the ears ( tinnitus )
  • beating heart ( palpitation er)
  • tightening of the throat
  • diarrhea
  • digestive problems ( dyspepsia )
  • dry mouth
  • muscle pain ( myalgia )
  • skeletal pain
  • chest pain
  • powerlessness ( asthenia )

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

  • spasm of the blood vessels of the heart (coronary vasospasm)
  • increased heart rate ( tachycardia )

No known frequency ( can not calculate from available data ): 

  • allergic reactions ( hypersensitivity reactions ), including mouth, throat, or hand edema ( angioedema )
  • severe allergic reactions (anaphylactic reactions)
  • convulsion (seizures)
  • visual impairment, blurred vision (visual disturbances can also occur during the migraine attack itself)
  • intestinal vasospasm, which may result in intestinal injury ( intestinal ischemia ). You may experience abdominal pain and bloody diarrhea.

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. 

5. How to store Almotriptan Orifarm

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

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

No special storage instructions.

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 almotriptan 12.5 mg (as 17.5 mg almotriptan malate).
  • Other ingredients are Tablet core: Microcrystalline cellulose, mannitol (E 421), povidone, sodium starch glycolate, sodium stearyl fumarate. Film coating: Hypromellose, titanium dioxide (E 171), macrogol, carnauba wax.

What the medicine looks like and the contents of the pack

White, round, biconvex film-coated tablet.

Almotriptan Orifarm is available in blister packs of 2, 3, 4, 6, 7, 9, 12, 14, or 18 film-coated tablets. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Orifarm Generics A / S

Energivej 15

5260 Odense S

Denmark

Local representative :

Orifarm Generics AB,

Box 56048

102 17 Stockholm

info@orifarm.com

Muhammad Nadeem

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