Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - tecovirimat

Document Subject

Generated Narrative: MedicinalProductDefinition mp13b9c5485a5dae25afc0e0c660688026

identifier: http://ema.europa.eu/identifier/EU/1/21/1600/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Tecovirimat SIGA 200 mg hard capsules

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-13b9c5485a5dae25afc0e0c660688026

identifier: http://ema.europa.eu/identifier/EU/1/21/1600/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - tecovirimat

Attesters

What is in this leaflet

1. What Tecovirimat SIGA is and what it is used for
2. What you need to know before you take Tecovirmat SIGA
3. How to take Tecovirimat SIGA
4. Possible side effects
5. How to store Tecovirimat SIGA
6. Contents of the pack and other information

Tecovirimat SIGA contains the active ingredient tecovirimat.

Tecovirimat SIGA is used to treat viral infections, such as smallpox, mpox and cowpox in adults and children weighing at least 13 kg.

Tecovirimat SIGA is also used to treat complications from smallpox vaccines.

Tecovirimat SIGA works by stopping the virus from spreading. This will help your own body to build up protection against the virus until you are better.

Do not take Tecovirimat SIGA

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Tecovirimat SIGA.

• if your immune system does not work properly (immunodeficiency) or you are taking medicines that weaken the immune system (such as high-dose corticosteroids, immunosuppresants or cancer medicines).
• If you have reduced function of your liver or kidneys.

Children weighing less than 13 kg

This medicine should not be given to children who weigh less than 13 kg.

Other medicines and Tecovirimat SIGA

Tell your doctor if you are taking, have recently taken or might take any other medicines.
You must tell your doctor if you are taking any of the following medicines:

• repaglinide (a medicine used to treat blood sugar levels in diabetes)
• omeprazole, lansoprazole, or rabeprazole (used to treat ulcers or heart burn)
• midazolam (a medicine used to put people to sleep before a surgical procedure)
• bupropion (a medicine used to treat depression)
• atorvastatin (a medicine use to treat high cholesterol)
• flurbiprofen (a medicine used to treat pain)
• methadone (a medicine used to treat pain or withdrawal symtoms of narcotics)
• darunavir, maraviroc, or rilpivirine (used to treat HIV infection)
• sildenafil, tadalafil, or vardenafil (used to treat erectile dysfunction)
• voriconazole (a medicine used to treat fungus infections)
• tacrolimus (a medicine used to suppress the immune system)

Taking Tecovirimat SIGA with any of these may stop your medicines from working properly, or make any side effects worse. Your doctor may need to give you a different medicine or adjust the dose of medicine you are taking. The above is not a complete list of medicines that your doctor may need to alter.

Pregnancy and breast-feeding

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Tecovirimat SIGA is not recommended during pregnancy.

It is not known whether Tecovirmat SIGA is excreted in human milk. Breast-feeding is not recommended during treatment with this medicine. Tell your doctor if you are breast-feeding or are planning to breast-feed before taking this medicine.

Driving and using machines

Do not drive or operate machines if you feel dizzy.

Tecovirimat SIGA contains Lactose and sunset yellow (E110)

• Tecovirimat SIGA contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
• This medicine also contains sunset yellow (E110), a colouring agent. This may cause allergic reactions.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Adults and children weighing at least 13 kg

The recommended doses are described in the table below.

Body Weight Dose 13 kg to less than 25 kg One Tecovirimat SIGA 200 mg capsule every 12 hours for 14 days (200 mg two times a day) 25 kg to less than 40 kg Two Tecovirimat SIGA 200 mg capsules every 12 hours for 14 days (400 mg two times a day) 40 kg to less than 120 kg Three Tecovirimat SIGA 200 mg capsules every 12 hours for 14 days (600 mg two times a day) 120 kg and above Three Tecovirimat SIGA 200 mg capsules every 8 hours for 14 days (600 mg three times a day)

Method of administration

Tecovirimat SIGA should be taken within 30 minutes of eating a meal of moderate calories and fat content.

Adults and children who have difficulty swallowing capsules

For patients who are not able to swallow the capsules, the doctor may recommend opening the hard capsule and mixing the contents with 30 mL of liquid (e.g., milk, chocolate milk) or soft food (e.g., apple sauce, yogurt).

Wash and dry your hands before and after preparation. Carefully open the capsule so that the contents do not spill or escape into the air. Hold the capsule with the cap facing up and pull the cap away from the body of the capsule. Use a small container for mixing. Mix the entire contents of the capsule with 30 mL of liquid (e.g. milk) or soft food (e.g. yogurt). The mixture should be taken within 30 minutes after mixing and within 30 minutes of eating a meal.

The recommended paediatric and adult dosage and preparation instructions are given in the table below.

Body weight Tecovirimat dose Amount of liquid or soft food Number of capsules Food and tecovirimat mixture instructions 13 kg to less than 25 kg 200 mg 2 tablespoons 1 Tecovirimat capsule Mix entire contents of 1 Tecovirimat capsule with 2 tablespoons of liquid or soft food. 25 kg to less than 40 kg 400 mg 2 tablespoons 2 Tecovirimat capsules Mix entire contents of 2 Tecovirimat capsules with 2 tablespoons of liquid or soft food. 40 kg to less than 120 kg 600 mg 2 tablespoons 3 Tecovirimat capsules Mix entire contents of 3 Tecovirimat capsules with 2 tablespoons of liquid or soft food. 120 kg and above 600 mg 2 tablespoons 3 Tecovirimat capsules Mix entire contents of 3 Tecovirimat capsules with 2 tablespoons of liquid or soft food.

If you take more Tecovirimat SIGA than you should

Let your doctor know if you take too many Tecovirimat SIGA capsules so that your doctor can monitor you for any signs or symptoms of side effects.

If you forget to take Tecovirimat SIGA

If you miss a dose, skip that dose and continue with your next scheduled dose. Do not take a double dose to make up for a forgotten dose.

If you stop taking Tecovirimat SIGA, your symptoms may return or become worse

Do not stop taking Tecovirimat SIGA before you have completed the course, or without talking to your doctor or pharmacist first.

If you vomit after taking Tecovirimat SIGA

If you vomit within 30 minutes of taking Tecovirimat SIGA, you may take another dose right away.
If you vomit more than 30 minutes after taking Tecovirimat SIGA, do not take another dose and continue with your next scheduled dose.

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

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

If you experience any of the following side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

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

• Headache

Common side effects (may affect up to 1 in 10 people)

• Dizziness
• Feeling sick (nausea) or vomiting
• Diarrhoea
• Abdominal pain

Uncommon side effects (may affect up to 1 in 100 people)

• Decreased appetite
• Increased liver enzymes
• Depression or anxiety
• Irritability
• Depression
• Panic attacks
• Migraine
• Feeling tired or sleepy or unable to sleep
• Being unable to concentrate or having a low attention span
• Taste disturbances
• Tingling or numbness in the hands, feet or or mouth
• Mouth pain
• Constipation
• Flatulence
• Indigestion or upset stomach
• Abdominal discomfort or swelling
• Dry mouth
• Dry or chapped lips
• Mouth ulcers
• Belching or burping
• Heartburn
• Itching or rash (hives)
• Joint pain and stiffness
• Fever
• Chills
• Generally feeling unwell (malaise)
• Pain
• Feeling thirsty
• If you have a scan of your brain s electrical activity called an electrocephalogram, it may show abnormal readings of electrical activity of the brain.
• If you have a blood test, it may show that you have lower numbers of red blood cells or white blood cells or platelets than usual.
• Increased heart rate (tachycardia) or irregular heart rate

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

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 bottle after EXP. The expiry date refers to the last day of that month.

Store in the original package in order to protect from light.

Store below 25 C.

Do not use this medicine if you notice that the capsule is broken or damaged in any way.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Tecovirimat SIGA contains

• The active substance is tecovirimat monohydrate equivalent to 200 mg tecovirimat
• The other ingredients are: Capsule core: Silica colloidal anhydrous, croscarmellose sodium (E468), hypromellose (E464), lactose monohydrate, magnesium stearate, cellulose, microcrystalline (E460) and sodium laurilsulfate (E487). Capsule shell: gelatin, brilliant blue FCF (E133), erythrosine (E127), sunset yellow (E110) and titanium dioxide (E171). Printing ink: shellac (E904), titanium dioxide (E171), isopropyl alcohol, ammonium hydroxide (E527), butyl alcohol, propylene glycol, and simeticone.

What Tecovirimat SIGA looks like and contents of the pack

• Tecovirimat SIGA are orange and black capsules, each printed with SIGA and ST-246 in white ink. The capsules are 21.7 millimeters long and 7.64 millimeters in diameter.
• Tecovirimat SIGA is available in a pack containing 84 (2 bottles of 42) capsules.

Marketing Authorisation Holder

SIGA Technologies Netherlands B.V. Prinsenhil 29, Breda 4825 AX, The Netherlands

Manufacturer

Millmount Healthcare Limited Block-7, City North Business Campus, Stamullen Co. Meath K32 YDIreland

This leaflet was last revised in

This medicine has been authorised under exceptional circumstances . This means that for ethical reasons it has been impossible to get complete information on this medicine. The European Medicines Agency will review any new information on this medicine every year and this leaflet will be updated as necessary.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: