OSELTAMIVIR HEC PHARM 75 mg HARD CAPSULES

Introduction

P

Oseltamivir HEC Pharm75mg hard capsules EFG

Read the entire leaflet carefully before starting to take the medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, ask your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Oseltamivir HEC Pharm is and what it is used for
2. What you need to know before taking Oseltamivir HEC Pharm
3. How to take Oseltamivir HEC Pharm
4. Possible side effects
5. Storage of Oseltamivir HEC Pharm
6. Contents of the pack and further information

1. What Oseltamivir HEC Pharm is and what it is used for

• Oseltamivir is used in adults, adolescents, children, and infants (including newborn babies) to treat flu(influenza). It can be used when you have flu symptoms and it is known that the flu virus is present in the population.
• Oseltamivir can also be prescribed to adults, adolescents, children, and infants over 1 year of age to prevent fluon a case-by-case basis, for example, if you have been in contact with someone who has the flu.
• Oseltamivir can be prescribed to adults, adolescents, children, and infants (including newborn babies) as a preventive treatmentin exceptional circumstances, for example, if there is a global flu epidemic (a flu pandemic) and when the seasonal flu vaccine cannot provide sufficient protection.

This medicine contains oseltamivir, which belongs to a group of medicines called neuraminidase inhibitors. These medicines prevent the spread of the flu virus in the body. They help to alleviate or prevent the symptoms of flu virus infection.

Flu is an infection caused by a virus. The signs of flu often include sudden fever (over 37.8°C), cough, runny or stuffy nose, headache, muscle pain, and extreme tiredness. These symptoms can also be caused by other infections. A true flu infection only occurs during annual outbreaks (epidemics), when flu viruses are widespread in the population. Outside of epidemic periods, flu-like symptoms are generally caused by another type of illness.

2. What you need to know before taking Oseltamivir HEC Pharm

Do not take Oseltamivir HEC Pharm:

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine

• if you are allergic to other medicines
• if you have any kidney disease. If so, your dose may need to be adjusted.
• if you have any severe illnessthat requires immediate hospitalization.
• if your immune systemis not working properly.
• if you have chronic heart diseaseor respiratory disease.

During treatment with oseltamivir, tell your doctor immediately

• if you notice changes in your behavior or mood(neuropsychiatric events), especially if they occur in children and adolescents. These can be signs of rare but serious side effects.

Oseltamivir HEC Pharm is not a flu vaccine

Oseltamivir is not a vaccine: it is used to treat the infection or prevent the spread of the flu virus. A vaccine provides you with antibodies against the virus. Oseltamivir does not affect the effectiveness of the flu vaccine, and your doctor may prescribe both.

Using Oseltamivir HEC Pharm with other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.

The following medicines are particularly important:

• chlorpropamide (used to treat diabetes)
• methotrexate (used to treat, for example, rheumatoid arthritis)
• phenylbutazone (used to treat pain and inflammation)
• probenecid (used to treat gout)

Pregnancy and breastfeeding

You should tell your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant, so that your doctor can decide if oseltamivir is suitable for you.

The effects on infants are unknown. You should tell your doctor if you are breastfeeding, so that your doctor can decide if oseltamivir is suitable for you.

Driving and using machines

Oseltamivir has no effect on your ability to drive or use machines.

Oseltamivir HEC Pharm contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per capsule; this is, essentially, "sodium-free".

3. How to take Oseltamivir HEC Pharm

Follow the instructions for taking oseltamivir exactly as indicated by your doctor. Ask your doctor or pharmacist if you have any questions.

Take oseltamivir as soon as possible, ideally within 2 days of starting to have flu symptoms.

Recommended doses

For the treatment of flu, take 2 doses daily. It is usually convenient to take one dose in the morning and one in the evening. It is essential to complete the entire 5-day treatment, even if you start to feel better quickly.

For adult patients with a weakened immune system, treatment will continue for 10 days.

For the prevention of flu or after being in contact with an infected person, take 1 dose daily for 10 days. It is best to take this dose in the morning with breakfast.

In special situations, such as widespread flu or patients with a weakened immune system, treatment will continue for 6 or 12 weeks.

The recommended dose depends on the patient's body weight.You should use the amount of capsules prescribed by your doctor.

It can be obtained 75 mg with a 30 mg capsule plus a 45 mg capsule

Children under 1 year (0 to 12 months)

The administration of oseltamivir to children under 1 year of age to prevent flu during a pandemic should be done based on the doctor's judgment after considering the potential benefits versus any potential risks to the child.

mg per kg = mg per kilogram of body weight of the child. For example:

If a 6-month-old child weighs 8 kg, the dose is

8 kg x 3 mg per kg = 24 mg

Method of administration

Swallow the capsules whole with water. Do not break or chew the capsules.

Oseltamivir can be taken with or without food, although taking it with food may reduce the possibility of feeling or having discomfort (nausea or vomiting).

People who may have difficulty swallowing the capsulescan use a liquid medicine, oseltamivir powder for oral suspension, which is the preferred product. If a liquid formulation of the medicine is needed but is not available, a suspension can be prepared with oseltamivir capsules (see the section Information for healthcare professionals). If the preparation is not available at the pharmacy, you can prepare a liquid formulation with oseltamivir capsules. See the page onPreparation ofOseltamivir HEC Pharm liquid at home.

If you take more Oseltamivir HEC Pharm than you should

Stop taking oseltamivir and consult a doctor or pharmacist immediately.

In many cases of overdose, no side effects were reported. When side effects were reported, they were similar to those that occurred with normal doses and are included in section 4.

Overdose cases with oseltamivir have been reported more frequently in children than in adults and adolescents. Caution should be exercised when preparing oseltamivir liquid for children and when administering oseltamivir capsules or liquid to children.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Oseltamivir HEC Pharm

Do not take a double dose to make up for forgotten doses.

If you stop taking Oseltamivir HEC Pharm

No side effects occur when you stop taking oseltamivir. However, if you stop taking oseltamivir before your doctor told you to, the flu symptoms may recur. Always complete the treatment prescribed by your doctor.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Many of these side effects may be caused by the flu.

Since the marketing of oseltamivir, the following serious side effects have been rarely reported:

• Anaphylactic and anaphylactoid reactions: severe allergic reactions, with swelling of the face and skin, rash with itching, low blood pressure, and difficulty breathing.
• Hepatic disorders (fulminant hepatitis, hepatic function disorder, and jaundice): yellowing of the skin and whites of the eyes, change in the color of the stool, changes in behavior.
• Angioedema: severe sudden swelling of the skin mainly around the head and neck area, including eyes and tongue, with difficulty breathing.
• Stevens-Johnson syndrome and toxic epidermal necrolysis: a complicated allergic reaction with possible life-threatening, severe inflammation of the outer and possibly inner skin, initially with fever, sore throat, and fatigue, skin rash with blistering, peeling, and large areas of skin peeled, possible difficulty breathing and low blood pressure.
• Gastrointestinal hemorrhage: prolonged bleeding from the large intestine or vomiting blood.
• Neuropsychiatric disorders, as described below.

If you notice any of these symptoms, seek medical help immediately.

Other side effects:

The most frequently reported side effects (very common and common) for oseltamivir are feeling unwell or discomfort (nausea, vomiting), stomach pain, stomach discomfort, headache, and pain. These side effects usually occur after the first dose of the medicine and generally tend to disappear during treatment. The frequency with which these side effects occur is reduced if the medicine is taken with food.

Rare but serious side effects: seek medical help immediately(These can affect up to 1 in 1,000 people)

During treatment with oseltamivir, rare side effects have been reported, including

• seizures and delirium, including altered levels of consciousness
• confusion, abnormal behavior
• delirious disorders, hallucinations, agitation, anxiety, nightmares

These events were mainly reported in children and adolescents and often started suddenly and had a rapid resolution. In very rare cases, these events resulted in self-harm, some with a fatal outcome. These neuropsychiatric events have also been reported in patients with flu who were not taking oseltamivir.

• Patient, especially children and adolescents, should be closely monitored to detect changes in behavior as described above.

If you notice any of these symptoms, especially in younger patients, seek medical help immediately.

Adults and adolescents 13 years and older

Very common side effects

(can affect more than 1 in 10 people)

• Headache
• Nausea

Common side effects

(can affect up to 1 in 10 people)

• Bronchitis
• Fever
• Cough
• Dizziness
• Fever
• Pain
• Limb pain
• Runny nose
• Difficulty sleeping
• Sore throat
• Stomach pain
• Fatigue
• Feeling of fullness in the upper abdomen
• Upper respiratory tract infections (inflammation of the nose, throat, and sinuses)
• Stomach discomfort
• Vomiting

Uncommon side effects

(can affect up to 1 in 100 people)

• Allergic reactions
• Altered level of consciousness
• Seizure
• Heart rhythm disorders
• Mild to severe liver function disorders
• Skin reactions (skin inflammation, red and itchy rash, scaly skin)

Rare side effects

(can affect up to 1 in 1,000 people)

• Thrombocytopenia (low platelet count)
• Vision disorders

Children 1 to 12 years

Very common side effects

(can affect more than 1 in 10 people)

• Cough
• Nasal congestion
• Vomiting

Common side effects

(can affect up to 1 in 10 people)

• Conjunctivitis (red and watery eyes or eye pain)
• Ear inflammation and other ear disorders
• Headache
• Nausea
• Runny nose
• Stomach pain
• Feeling of fullness in the upper abdomen
• Stomach discomfort

Uncommon side effects

(can affect up to 1 in 100 people)

• Skin inflammation
• Tympanic membrane disorder (eardrum)

Infants under 1 year

The side effects reported in children from 0 to 12 months of age are mostly similar to the side effects reported in older children (from 1 year onwards). Additionally, diarrhea and diaper rash have been reported.

If you think any of the side effects you are experiencing is serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist. However,

• if you or your child are sick several times, or
• if flu symptoms worsen or fever continues

Tell your doctor as soon as possible.

Reporting side effects

If you experience any side effects, ask your doctor, even if they are possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Oseltamivir HEC Pharm

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

Do not use this medicine after the expiry date stated on the packaging and on the blister after EXP. The expiry date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at the pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Container Contents and Additional Information

Composition of Oseltamivir HEC Pharm

The active ingredient is oseltamivir.

• Each hard capsule contains oseltamivir phosphate equivalent to 75 mg of oseltamivir.
• The other ingredients are:

capsule content: pregelatinized corn starch, sodium croscarmellose, povidone, sodium stearyl fumarate, and talc.

capsule shell: gelatin, brilliant blue FCF/blue FD&C No. 1 (E133), quinoline yellow, titanium dioxide (E171).

printing ink: shellac, potassium hydroxide, black iron oxide (E172).

Product Appearance and Container Contents

Hard capsule consisting of a white opaque body with no inscription and a green opaque cap with the inscription «S2». The inscriptions are black.

Oseltamivir HEC Pharm 75 mg hard capsules are available in blisters of 10 capsules.

Marketing Authorization Holder

HEC Pharm GmbH

Gabriele-Tergit-Promenade 17

10963 Berlin

Germany

Manufacturer

Formula Pharmazeutische und chemische Entwicklungs GmbH

Goerzallee 305b

14167 Berlin

Germany

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the last revision of this leaflet: April 2020.

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

-------------------------------------------------------------------------------------------------------------------------- Information for the User

For people who find it difficult to swallow the capsules, including very small children, oseltamivir powder for oral suspension is available, which is the preferred product. If a liquid presentation of the medicinal product is needed but is not available, a suspension can be prepared in the pharmacy with Oseltamivir HEC Pharm capsules (see the section Information for Healthcare Professionals). The preparation made in the pharmacy is the recommended option.

If the pharmacy preparation is also not available, you can prepare Oseltamivir HEC Pharm liquid at home from these capsules.

The dose is the same for the treatment as for the prevention of influenza. The difference is the frequency at which it is administered.

Preparation of Oseltamivir HEC Pharm Liquid at Home

• If you have the correct capsulefor the necessary dose (a 75 mg dose), open the capsule and mix its contents in a spoonful (or less) of suitable sweetened food. This is normally suitable for children over 1 year of age. See the top section of theinstructions.

• If you need smaller doses, preparing Oseltamivir HEC Pharm liquid from the capsules requires more steps. This is suitable for small children and babies: they need a dose of oseltamivir of less than 30 mg. See the lower section of the instructions.

Adults, adolescents from 13 years of age, and children with a weight of 40 kg or more

To make a 75 mg dose, you will need:

• One Oseltamivir HEC Pharm 75 mg capsule(s)
• Sharp scissors
• A small container
• A spoon (5 ml spoon)
• Water
• Sweetened foodto mask the bitter taste of the powder

Examples: chocolate syrup or cherry syrup and dessert sauce, such as caramel or condensed milk.

Or you can prepare sugared water by mixing one spoonful of water with three-quarters (3/4) of a spoonful of sugar.

Step 1: Check the correct dose

To know the correct amount to use, look for the patient's weight on the left side of the table.

Look at the right column to check the number of capsules that you will need to give to the patient for a single dose. The amount is the same for the treatment as for the prevention of influenza.

You should only use the 75 mg capsules for 75 mg doses. Do not attempt to prepare 75 mg doses using the contents of the 30 mg and 45 mg capsules.

It is not indicated in children who weigh less than 40 kg.

In the case of children who weigh less than 40 kg, you will need to prepare a dose of less than 75 mg. Consult the following information.

Step 2: Pour all the powder into the container

Take a 75 mgcapsule in a vertical position over a container and carefully cut the rounded end with scissors.

Pour all the powder into the container.

Be careful with the powder, as it can be irritating to the skin and eyes.

Step 3: Sweeten the powder and give the dose

Add a small amount - no more than one spoonful - of sweetened food to the powder in the container.

This is to mask the bitter taste of the Oseltamivir HEC Pharm powder.

Mix well.

Give the patient the entire contentsof the container immediately.

If some mixture remainsin the container, rinse the container with a small amount of water and have the patient drink it all. For children who cannot drink directly from the container, give it to them with a spoon or use an appropriate bottle to give the child the remaining liquid.

Give the child something to drink.

Repeat this procedure each time you need to give the medicine.

Infants under 1 year of age and children who weigh less than 40 kg

To make a smaller single dose, you will need:

• One Oseltamivir HEC Pharm 75 mg capsule
• Sharp scissors
• Two small containers(use different containers for each child)
• A large oral dose dispenserto measure the water - a 5 or 10 ml dispenser
• A small oral dose dispenserthat shows 0.1 ml measurements to give the dose
• A spoon (5 ml spoon)
• Water
• Sweetened foodto mask the bitter taste of Oseltamivir HEC Pharm

Examples: chocolate syrup or cherry syrup and dessert sauce, such as caramel or condensed milk.

Or you can prepare sugared water: mix one spoonful of water with three-quarters (3/4) of a spoonful of sugar.

Step 1: Pour all the powder into a container

Take a 75 mgcapsule in a vertical position over one of the containers and carefully cut the rounded end with scissors. Be careful with the powder, as it can be irritating to the skin and eyes.

Pour all the powder into the container, regardless of the dose you are preparing.

The amount is the same for the treatment as for the prevention of influenza.

Step 2: Add water to dilute the medicine

Do not worry if not all the powder dissolves. The undissolved powder corresponds to inactive ingredients.

Step 3: Choose the correct amount for the child's weight

Look for the child's weight in the left column of the table.

The right column of the table shows how much of the liquid mixture you will need to prepare.

Infants under 1 year of age (including full-term newborns)

Children from 1 year of age who weigh less than 40 kg

Step 4: Prepare the liquid mixture

Make sure you have the correct dispenser size.

Carefully prepare the correct amount of liquid mixture from the first container.

Prepare it carefully to avoid taking air bubbles.

Gently add the correct dose to the second container.

Step 5: Sweeten and give to the child

Add a small amount - no more than one spoonful - of sweetened food to the second container.

This is to mask the bitter taste of the Oseltamivir HEC Pharm suspension.

Mix the sweetened food well with the Oseltamivir HEC Pharm liquid.

Give the child the entire contentsof the second container (sweetened food with the Oseltamivir HEC Pharm liquid mixture) immediately.

If some mixture remainsin the second container, rinse the container with a small amount of water and have the child drink it all. For children who cannot drink directly from the container, give it to them with a spoon or use an appropriate bottle to give the child the remaining liquid.

Give the child something to drink.

Discard any remaining liquidfrom the first container.

Repeat this procedure each time you need to give the medicine.

--------------------------------------------------------------------------------------------------------------------------- Information for Healthcare Professionals Only

Patients who cannot swallow the capsules:

The commercial presentation of oseltamivir for oral suspension (6 mg/ml) is the medicinal product of choice for pediatric and adult patients who have difficulty swallowing the capsules or who need lower doses. If oseltamivir powder for oral suspension is not available, the pharmacist can prepare a suspension (6 mg/ml) from Oseltamivir HEC Pharm capsules. If the suspension prepared in the pharmacy is also not available, patients can prepare the suspension at home from the capsules.

Oral dose dispensersshould be provided with the appropriate volume and graduation to administer the suspension prepared in the pharmacy and for the procedures to follow for home preparation. In both cases, the volumes needed should preferably be marked on the dispensers. For home preparation, the dispensers to take the correct volume of water and to measure the Oseltamivir HEC Pharm mixture with water should be provided separately. To measure 12.5 ml of water, 5 ml or 10 ml dispensers should be used.

The following shows the suitable dispenser size to draw the correct volume of oseltamivir suspension (6 mg/ml).

Infants under 1 year of age (including full-term newborns):

Children from 1 year of age who weigh less than 40 kg