Patient Information Leaflet: Contraindications and Warnings

Onavuo 120 mg Hard Gastrorresistant Capsules EFG

Onavuo 240 mg Hard Gastrorresistant Capsules EFG

Dimethyl Fumarate

Read this leaflet carefully before you start taking this medicine because 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. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

What is Onavuo

Onavuo is a medication that containsdimethyl fumarateas the active ingredient.

What is Onavuo used for

Dimethyl fumarate isused to treat relapsing-remitting multiple sclerosis (MS) in patients 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-remitting MS is characterized by repeated attacks (exacerbations) of neurological symptoms. Symptoms vary from patient to patient but often include: difficulties walking, balance problems, and visual problems (e.g., blurred or double vision). These symptoms may disappear completely when the exacerbation ends, but some problems may persist.

How Onavuo works

Dimethyl fumarate appears to act by preventing the body's defense system from damaging the brain and spinal cord. This may also help delay future MS deterioration.

Do not take Onavuo

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

Warnings and precautions

Dimethyl fumarate may affect yourwhite blood cell count, yourkidneysand yourliver. Before starting dimethyl fumarate, your doctor will do a blood test to get a white blood cell count and check that your kidneys and liver are working properly. Your doctor will do blood tests periodically during treatment. If you experience a decrease in white blood cell count during treatment, your doctor may consider additional tests or stop your treatment.

Consult your doctorbefore starting to take this medicine if you have:

• severerenal disease,
• severehepatic disease,
• a disease of thestomachor theintestine,
• a severeinfection(for example pneumonia).

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

If you think your MS is getting worse (e.g., weakness or changes in vision) or notice the appearance of any new symptoms, speak directly with your doctor, as they may 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 that contains dimethyl fumarate in combination with other fumaric acid esters, and that is used to treat psoriasis (a skin disease). If you notice that you are urinating more, are more thirsty and drink more than usual, your muscles seem weaker, you break a bone or simply have pain and discomfort, 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 are no available data in this age group.

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Other medicines and Onavuo

Inform your doctor or pharmacistif you are taking, have taken recently or may need to take any other medicine, in particular:

• medicines that containfumaric acid esters(fumarates) used to treat psoriasis,
• medicines that affect the body's immune system, includingchemotherapy, immunosuppressantsor other medicines used to treat MS,
• medicines that affect the kidneys, includingsomeantibiotics(used to treat infections),diuretics(tablets that increase urine elimination),some types of analgesics(such as ibuprofen or other anti-inflammatory drugs, and over-the-counter medicines) and medicines that containlithium,
• the use of dimethyl fumarate and the administration of certain types of vaccines (live vaccines)may cause an infection and, therefore, should be avoided. Your doctor will indicate if you should receive other types of vaccines (inactivated vaccines).

Onavuo and alcohol

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medicine.

Pregnancy

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

Breastfeeding

It is unknown whether dimethyl fumarate passes into breast milk. Your doctor will inform you if you should stop breastfeeding or if you should stop taking dimethyl fumarate. This decision involves weighing the benefits of breastfeeding for your child and the benefits of treatment for you.

Driving and operating machines

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

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor again.

Starting Dose

120 mg twice a day.

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

Usual Dose

240 mg twice a day.

Onavuo is taken orally.

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

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

Take Onavuo with food , which helps to reduce some of the very frequent 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 in section 4.

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

If you forget to take Onavuo

Do not take a double dose to compensate for the missed doses.

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

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

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

Severe side effects

Methylphenidate hydrochloride 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 cells throughout treatment and you should be aware of any possible symptoms of PML, as described below. The risk of PML may be higher if you have previously taken a medicine that has worsened your immune system function.

The symptoms of PML can be similar to those of an MS relapse. Symptoms may include new or worsening weakness on one side of the body; clumsiness; changes in vision, thinking, or memory; or confusion or changes in personality, or difficulty speaking and communicating that may persist for more than a few days. Therefore, it is very important to talk to your doctor as soon as possible if you think your MS is getting worse or if you notice any new symptoms while taking methylphenidate hydrochloride. Also, inform your partner or caregivers about your treatment.It is possible that symptoms may not be noticed by yourself.

??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 (unknown frequency).

Flushing of the face or body (flushing) is a very common side effect..However, if flushing is accompanied by a red rash or hives and you experience any of the following symptoms:

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

it may then constitute 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)

• flushing of the face or body with a sensation of heat, heat, burning sensation, or itching (flushing),
• diarrhea,
• nausea,
• abdominal pain or cramps.

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

While taking methylphenidate hydrochloride, it is common for urine tests to show ketones, substances that are naturally produced in the body.

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

Common(may affect up to 1 in 10 people)

• inflammation of the intestinal mucosa (gastroenteritis),
• nausea (vomiting),
• indigestion (dispepsia),
• inflammation of the stomach mucosa (gastritis),
• gastrointestinal disorders,
• burning sensation,
• heat, sweating, or itching,
• skin itching (pruritus),
• exanthema,
• rosy or reddish spots on the skin (erythema),
• hair loss (alopecia).

Side effects that may appear in blood or urine tests

• low white blood cell count (leukopenia) 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) inform your doctor immediately,
• protein (albumin) in urine,
• increase in liver enzymes (ALT, AST) in blood.

Rare(may affect up to 1 in 100 people)

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

Unknown(frequency cannot be estimated from available data)

• inflammation of the liver and increase in liver enzymes (ALT or AST simultaneously with bilirubin),
• herpes zoster (shingles) with symptoms such as blisters, burning, itching, or pain on 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 the infection, followed by numbness, itching, or red spots with intense pain,
• nasal secretion (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, for example, headache, abdominal pain or cramps, nausea, sore throat, cough, and painful menstruation.

Reporting side effects

If you experience any type of side effect, consult your doctoror,pharmacist,even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the carton box, blister pack, or bottle after CAD/EXP. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from light.

Medications should not be disposed of through drains or trash.Deposit containers and medications you no longer need at the SIGRE point of your pharmacy.If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Onavuo

• The active principleis dimethyl fumarate.

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

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

• The other components are:

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

Capsule coating: 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).

Appearance of the product and packaging content

Onavuo 120 mg hard-gastrorresistant capsules

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

Onavuo 240 mg hard-gastrorresistant capsules

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

Onavuo 120 mg hard-gastrorresistant capsules

OPA/Al/PVC//Al blister or precut unidose blisters.

Packaging sizes: 14, 14 x 1 capsules.

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

Packaging size: 100 capsules.

Onavuo 240 mg hard-gastrorresistant capsules

OPA/Al/PVC//Al blister or precut unidose blisters.

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

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

Packaging size: 100 capsules.

Only some packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible manufacturer

Pharmadox Healthcare Limited

Kw20a Kordin Industrial EstatePLA 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) with the following names:

Last review date 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.