ONAVUO 120 mg HARD GASTRO-RESISTANT CAPSULES

Introduction

Package Leaflet: Information for the Patient

Onavuo 120 mg Hard Gastro-Resistant Capsules EFG

Onavuo 240 mg Hard Gastro-Resistant Capsules EFG

Dimethyl Fumarate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Onavuo and what is it used for

What is Onavuo

Onavuo is a medicine that contains dimethyl fumarateas the active substance.

What Onavuo is used for

Dimethyl fumarate is used to treat multiple sclerosis (MS) with relapses in patients from 13 years of age and older.

MS is a long-term disease that affects the central nervous system (CNS), which includes the brain and spinal cord. Relapsing MS is characterized by repeated attacks (relapses) of neurological symptoms. The symptoms vary from person to person but often include: difficulties in walking, balance disturbances, and visual problems (e.g., blurred or double vision). These symptoms can disappear completely when the relapse is over, but some problems may remain.

How Onavuo works

Dimethyl fumarate seems to work by preventing the body's defense system from damaging the brain and spinal cord. This may also help to delay future disability in MS.

2. What you need to know before you take Onavuo

Do not take Onavuo

• if you are allergic to dimethyl fumarateor any of the other ingredients of this medicine (listed in section 6).
• if you are suspected to suffer from a rare brain infection called progressive multifocal leukoencephalopathy (PML) or if PML has been confirmed.

Warnings and precautions

Dimethyl fumarate may affect your white blood cell count, kidneys, and liver. Before starting treatment with dimethyl fumarate, your doctor will perform a blood test to check your white blood cell count and to ensure that your kidneys and liver are working properly. Your doctor will perform regular blood tests during treatment. If you experience a decrease in your white blood cell count during treatment, your doctor may consider additional tests or interrupt your treatment.

Consult your doctorbefore starting treatment with this medicine if you have:

• severe kidney disease,
• severe liver disease,
• a stomach or intestinal disease,
• a severe infection(e.g., pneumonia).

Herpes zoster (shingles) may occur during treatment with dimethyl fumarate. In some cases, serious complications have occurred. You must inform your doctor immediatelyif you suspect you have any symptoms of shingles.

If you think your MS is getting worse (e.g., weakness or changes in vision) or you notice the appearance of any new symptoms, talk to your doctor directly, as they could be symptoms of a rare brain infection called PML. PML is a serious disease that can cause death or severe disability.

A rare but serious kidney disorder (called Fanconi syndrome) has been reported with a medicine containing dimethyl fumarate in combination with other fumaric acid esters, which is used to treat psoriasis (a skin disease). If you notice that you are urinating more, are thirstier, and drink more than usual, your muscles seem weaker, you break a bone, or you simply have aches and pains, inform your doctor as soon as possible so that this can be investigated further.

Children and adolescents

Do not give this medicine to children under 10 years of age because there is no data available for this age group.

Other medicines and Onavuo

Tell your doctor or pharmacistif you are taking, have recently taken, or might take any other medicines, in particular:

• medicines containing fumaric acid esters(fumarates) used to treat psoriasis,
• medicines that affect the body's immune system, including chemotherapy, immunosuppressants, or other medicines used to treat MS;
• medicines that affect the kidneys, includingsome antibiotics(used to treat infections), diuretics(pills that increase urine production), certain types of painkillers(such as ibuprofen or similar anti-inflammatory medicines, and over-the-counter medicines) and medicines that contain lithium,
• the use of dimethyl fumarate and the administration of certain types of vaccines (live vaccines) could cause you to become infected, and therefore, should be avoided. Your doctor will tell you if you should receive other types of vaccines (inactivated vaccines).

Taking Onavuo with alcohol

After taking dimethyl fumarate, you should avoid consuming more than a small amount (more than 50 ml) of strong alcoholic beverages (with an alcohol content of more than 30%, such as spirits) for the first hour, because alcohol may interact with this medicine. This may cause stomach inflammation (gastritis), especially in people who are prone to this condition.

Pregnancy and breastfeeding

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.

Pregnancy

Information on the effects of this medicine when used during pregnancy is limited. Do not take dimethyl fumarate during pregnancy unless you have discussed this with your doctor and this medicine is clearly necessary for you.

Breastfeeding

It is not known whether dimethyl fumarate passes into breast milk. Your doctor will inform you whether you should stop breastfeeding, or whether you should stop taking dimethyl fumarate. This decision will involve weighing the benefits of breastfeeding for your child and the benefits of treatment for you.

Driving and using machines

Dimethyl fumarate is not expected to affect your ability to drive or use machines.

3. How to take Onavuo

Follow the instructions for administration of this medicine exactly as told by your doctor. If you are unsure, consult your doctor again.

Initial dose

120 mg twice a day.

Take this initial dose for the first 7 days, then take the usual dose.

Usual dose

240 mg twice a day.

Onavuo is taken orally.

The capsules should be swallowed whole, with some water. Do not break, crush, dissolve, suck, or chew the capsules, as this may increase some side effects.

The bottles contain a desiccant. Do not swallow the desiccant.

Take Onavuo with food, this helps to reduce some of the very common side effects (listed in section 4).

If you take more Onavuo than you should

If you take too many capsules, tell your doctor immediately. You may experience side effects similar to those described below in section 4.

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 taken.

If you forget to take Onavuo

Do not take a double doseto make up for forgotten doses.

You can take the forgotten dose if at least 4 hours have passed between doses. Otherwise, wait until the next dose.

If you have any further questions on 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.

Serious side effects

Dimethyl fumarate may decrease your lymphocyte count (a type of white blood cell). A low white blood cell count can increase the risk of infection, including a rare brain infection called progressive multifocal leukoencephalopathy (PML). PML can cause death or severe disability. PML has occurred after 1 to 5 years of treatment, so your doctor must continue to monitor your white blood cell count during treatment, and you must remain alert to any possible symptoms of PML, as described below. The risk of PML may be greater if you have previously taken a medicine that has weakened your immune system.

The symptoms of PML can be similar to those of an MS relapse. The symptoms can include new or worsening weakness on one side of the body; clumsiness; changes in vision, thinking, or memory; or confusion or personality changes, or difficulty speaking and communicating that may persist for more than several days. Therefore, it is very important that you talk to your doctor as soon as possible if you think your MS is getting worse or if you notice any new symptoms while being treated with dimethyl fumarate. Also, inform your partner or caregivers about your treatment. It is possible that symptoms may arise that you are not aware of on your own.

Call your doctor immediately if you experience any of these symptoms

Severe allergic reactions

The frequency of severe allergic reactions cannot be estimated from the available data (frequency not known).

Facial or body redness (flushing) is a very common side effect.However, if the redness is accompanied by a rash or hivesandyou experience any of the following symptoms:

• swelling of the face, lips, mouth, or tongue (angioedema),
• wheezing, difficulty breathing, or shortness of breath (dyspnea, hypoxia),
• dizziness or loss of consciousness (hypotension),

this could be a severe allergic reaction (anaphylaxis).

Stop taking Onavuo and call your doctor immediately.

Other side effects

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

• facial or body redness with a feeling of heat, heat, burning sensation, or itching (flushing),
• loose stools (diarrhea),
• feeling unwell (nausea),
• stomach pain or cramps.

Taking the medicine with foodmay help reduce these side effects.

While being treated with dimethyl fumarate, it is common for urine tests to show the presence of ketones, substances that are naturally produced by the body.

Consult your doctorabout how to treat these side effects. Your doctor may reduce your dose. Do not reduce the dose unless your doctor tells you to.

Common(may affect up to 1 in 10 people)

• inflammation of the intestinal mucosa (gastroenteritis),
• feeling sick (vomiting),
• indigestion (dyspepsia),
• inflammation of the stomach mucosa (gastritis),
• gastrointestinal disorders,
• burning sensation,
• hot flashes, feeling of heat,
• skin itching (pruritus),
• rash,
• red patches or redness of the skin (erythema),
• hair loss (alopecia).

Side effects that may appear in blood or urine tests

• low white blood cell count (lymphopenia, leucopenia) in blood. A decrease in white blood cells can make the body less able to fight infections. If you have a severe infection (such as pneumonia), tell your doctor immediately,
• proteins (albumin) in urine,
• increased liver enzymes (ALT, AST) in blood.

Uncommon(may affect up to 1 in 100 people)

• allergic reactions (hypersensitivity),
• reduction of blood platelets.

Not known(frequency cannot be estimated from the available data)

• inflammation of the liver and increased liver enzymes (ALT or AST simultaneously with bilirubin),
• herpes zoster (shingles) with symptoms such as blisters, burning, itching, or pain of the skin, usually on one side of the upper body or face, and other symptoms, such as fever and weakness in the early stages of infection, followed by numbness, itching, or red spots with severe pain,
• nasal discharge (rhinorrhea).

Children (13 years of age and older) and adolescents

The side effects described above also apply to children and adolescents.

Some side effects were reported more frequently in children and adolescents than in adults, e.g., headache, stomach pain or cramps, feeling sick (vomiting), sore throat, cough, and painful menstruation.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Onavuo

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 carton, blister, or bottle after EXP. The expiry date refers to the last day of the month shown.

Store in the original package to protect from light.

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

6. Container Content and Additional Information

Onavuo Composition

• The active ingredient is dimethyl fumarate.

Onavuo 120 mg gastro-resistant hard capsules: each capsule contains 120 mg of dimethyl fumarate.

Onavuo 240 mg gastro-resistant hard capsules: each capsule contains 240 mg of dimethyl fumarate.

• The other components are:

Capsule content: microcrystalline cellulose, povidone K-30, crospovidone, anhydrous colloidal silica, magnesium stearate, hypromellose, triacetin, talc, methacrylic acid - ethyl acrylate copolymer (1:1), titanium dioxide (E171), triethyl citrate.

Capsule shell: gelatin, titanium dioxide (E171), yellow iron oxide (E172), brilliant blue FCF (E133); Capsule ink: shellac, propylene glycol (E1520), concentrated ammonia solution, potassium hydroxide, black iron oxide (E172).

Product Appearance and Container Content

Onavuo 120 mg gastro-resistant hard capsules

They are green and white gelatin gastro-resistant hard capsules, size 0, approximately 21.4 mm in length, printed with “DMF 120” containing white to almost white mini-tablets.

Onavuo 240 mg gastro-resistant hard capsules

They are green gelatin gastro-resistant hard capsules, size 00, approximately 23.2 mm in length, printed with “DMF 240” containing white to almost white mini-tablets.

Onavuo 120 mg gastro-resistant hard capsules

Blister or pre-cut unit-dose OPA/Al/PVC//Al blisters.

Container sizes: 14, 14 x 1 capsules.

HDPE bottle with PP/HDPE cap sealed and with a silica gel desiccant plug.

Container size: 100 capsules.

Onavuo 240 mg gastro-resistant hard capsules

Blister or pre-cut unit-dose OPA/Al/PVC//Al blisters.

Container sizes: 56, 56 x 1, 168, 168 x 1, and 196 capsules.

HDPE bottle with PP/HDPE cap sealed and with a silica gel desiccant plug.

Container size: 100 capsules.

Only some container sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Pharmadox Healthcare Limited

Kw20a Kordin Industrial Estate

PLA 3000 Paola,

Malta

or

Adalvo Limited

Malta Life Sciences Park, Building 1, Level 4

Sir Temi Zammit Buildings

SGN 3000 San Gwann,

Malta

or

Lek Pharmaceuticals D.D.

Verovskova Ulica 57

1526 Ljubljana,

Slovenia

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Date of the Last Revision of this Leaflet:

06/2024

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.