Onavuo 240 mg gastro-resistant hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Onavuo 120 mg gastro-resistant hard capsules EFG

Onavuo 240 mg gastro-resistant hard capsules EFG

dimethyl fumarate

Read the entire leaflet carefully before you start taking this 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 for you only and must not be given to other people, even if they have the same symptoms as you, since it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Onavuo is and what it is used for

What Onavuo is

Onavuo is a medicine that contains dimethyl fumarate as the active substance.

What Onavuo is used for

Dimethyl fumarate is used to treat relapsing-remitting multiple sclerosis (MS) in patients aged 13 years and older.

MS is a long-term disease that affects the central nervous system (CNS), which includes the brain and spinal cord. Relapsing-remitting MS is characterized by repeated attacks (relapses) of neurological symptoms. Symptoms vary from patient to patient but commonly include: difficulty walking, balance disturbances, and visual problems (e.g., blurred or double vision). These symptoms may completely disappear when a relapse ends, although some problems may persist.

How Onavuo works

Dimethyl fumarate appears to work by preventing the body's immune system from damaging the brain and spinal cord. This may also help delay future progression of MS.

2. What you need to know before starting Onavuo

Do not take Onavuo

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

Warnings and precautions

Dimethyl fumarate may affect the number of white blood cells, the kidneys, and the liver. Before you start taking dimethyl fumarate, your doctor will perform a blood test to determine your white blood cell count and to check that your kidneys and liver are functioning properly. Your doctor will carry out periodic blood tests during treatment. If you experience a decrease in white blood cell count during treatment, your doctor may consider additional testing or interrupt your treatment.

Consult your doctor before starting this medicine if you have:

• severe renal disease,
• severe hepatic disease,
• a stomach or intestinal disorder,
• a serious 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 immediately if you suspect you have any symptoms of shingles.

If you think your MS is worsening (e.g., weakness or visual changes) or you develop any new symptoms, speak to your doctor immediately, as these could be symptoms of a rare brain infection called PML. PML is a serious illness that can be fatal or cause 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, used to treat psoriasis (a skin disease). If you notice that you are urinating more than usual, feel unusually thirsty and drink more than normal, your muscles seem weaker, you experience a bone fracture, or you have unexplained aches and pains, inform your doctor as soon as possible so that this can be further investigated.

Children and adolescents

Do not give this medicine to children under 10 years of age, as there are no available data in this age group.

Other medicines and Onavuo

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, especially:

• 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, including certain antibiotics (used to treat infections), diuretics (tablets that increase urine output), certain types of painkillers (such as ibuprofen or other similar anti-inflammatory medicines, and over-the-counter medications), and medicines containing lithium,
• using dimethyl fumarate together with certain types of vaccines (live vaccines) could cause you to develop an infection and should therefore be avoided. Your doctor will advise you whether other types of vaccines (inactivated vaccines) should be administered.

Taking Onavuo with alcohol

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

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

Breastfeeding

It is unknown whether dimethyl fumarate passes into breast milk. Your doctor will advise you whether you should stop breastfeeding or stop taking dimethyl fumarate. This decision involves weighing the benefits of breastfeeding for your child against 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 exactly the instructions for using this medicine given by your doctor. If in doubt, consult your doctor again.

Starting dose

120 mg twice daily.

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

Usual dose

240 mg twice daily.

Onavuo is taken orally.

The capsules must be swallowed whole with some water. Do not split, crush, dissolve, suck, or chew the capsules, as some adverse effects may increase.

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

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

If you take more Onavuo than you should

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

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

If you forget to take Onavuo

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

You may take the missed dose if there are at least 4 hours between doses. Otherwise, wait until the time of the next dose.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Serious adverse effects

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

Symptoms of PML may be similar to those of an MS relapse. Symptoms may include new weakness or worsening of weakness on one side of the body; clumsiness; changes in vision, thinking, or memory; confusion or personality changes; or difficulty speaking and communicating that may last for more than several days. Therefore, it is very important that you speak to your doctor as soon as possible if you think your MS is worsening or if you notice any new symptoms while being treated with dimethyl fumarate. In addition, inform your partner or caregivers about your treatment. Symptoms may arise that you yourself do not notice.

??Call your doctor immediately if you experience any of these symptoms

Serious allergic reactions

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

Flushing of the face or body (rubefaction) is a very common adverse effect. However, if flushing is accompanied by a red skin rash or rash and you 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 then represent a serious allergic reaction (anaphylaxis).

? Stop taking Onavuo and call your doctor immediately.

Other adverse effects

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

• flushing of the face or body with sensation of warmth, heat, burning sensation, or itching (rubefaction),
• loose stools (diarrhea),
• feeling unwell (nausea),
• stomach pain or cramps.

? Taking the medicine with food may help reduce the above adverse effects.

While being treated with dimethyl fumarate, urine tests frequently show the presence of ketones, substances that are naturally produced in the body.

Consult your doctor about how to manage these adverse effects. Your doctor may reduce your dose. Do not reduce your dose unless instructed by your doctor.

Common (may affect up to 1 in 10 people)

• inflammation of the intestinal lining (gastroenteritis),
• feeling sick (vomiting),
• indigestion (dyspepsia),
• inflammation of the stomach lining (gastritis),
• gastrointestinal disorders,
• burning sensation,
• hot flushes, feeling of warmth,
• skin itching (pruritus),
• rash,
• rosacea-like or reddish skin spots (erythema),
• hair loss (alopecia).

Adverse effects that may appear in blood or urine tests

• low levels of white blood cells (lymphopenia, leucopenia) in blood. A decrease in white blood cells may reduce the body's ability to fight infections. If you develop a serious infection (such as pneumonia), inform 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 in blood platelets.

Not known (frequency cannot be estimated from available data)

• inflammation of the liver and increased levels of liver enzymes (ALT or AST simultaneously with bilirubin),
• herpes zoster (shingles), with symptoms such as blisters, burning, itching, or skin pain, 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 painful red spots,
• runny nose (rhinorrhea).

Children (aged 13 years and older) and adolescents

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

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

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse 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 stated on the cardboard box, blister pack, or bottle after CAD/EXP. The expiry date refers to the last day of the month indicated.

Store in the original packaging to protect from light.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point in your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Onavuo

• The active substance 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 contents: microcrystalline cellulose, povidone K-30, crospovidone, anhydrous colloidal silica, magnesium stearate, hypromellose, triacetin, talc, methacrylic acid and ethyl acrylate copolymer (1:1), titanium dioxide (E171), triethyl citrate.

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

Nature and contents of the container

Onavuo 120 mg gastro-resistant hard capsules

Gastro-resistant hard gelatin capsules, green and white in colour, 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

Gastro-resistant hard gelatin capsules, green in colour, 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 single-dose precut blisters OPA/Al/PVC//Al.

Pack sizes: 14, 14 x 1 capsules.

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

Pack size: 100 capsules.

Onavuo 240 mg gastro-resistant hard capsules

Blister or single-dose precut blisters OPA/Al/PVC//Al.

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

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

Pack size: 100 capsules.

Only certain pack 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 European Economic Area Member States and in the United Kingdom (Northern Ireland) under the following names:

Date of the most recent review of this leaflet:

06/2024

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