Fendivia 12 micrograms/hour transdermal patch: detailed information

Patient Information Leaflet

Introduction

Patient Information Leaflet

Fendivia 12 micrograms/hour transdermal patch

Fendivia 25 micrograms/hour transdermal patch

Fendivia 50 micrograms/hour transdermal patch

Fendivia 75 micrograms/hour transdermal patch

Fendivia 100 micrograms/hour transdermal patch

fentanyl

Read the entire leaflet carefully before you start using 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, pharmacist or nurse.
This medicine has been prescribed for you (or your child) only. Do not give it to others, even if they have the same symptoms as you, since it could harm them.
If you experience any side effects, talk to your doctor, pharmacist or nurse, even if the side effects are not listed in this leaflet. See section 4.

Leaflet Contents

What Fendivia is and what it is used for
What you need to know before using Fendivia
How to use Fendivia
Possible side effects
How to store Fendivia
Contents of the pack and other information

1. What Fendivia is and what it is used for

The name of your medicine is Fendivia.

The patches help relieve severe and long-lasting pain:

in adults who require continuous pain treatment
in children over 2 years of age who are already using opioid medication and require continuous pain treatment.

Fendivia contains a medicine called fentanyl. It belongs to a group of strong pain-relieving medicines called opioids.

2. What you need to know before using Fendivia

Do not use Fendivia:

If you are allergic to fentanyl or any of the other components of this medicine (listed in section 6).
If you have short-term pain, such as sudden pain or pain after surgery.
If you have difficulty breathing, with slow or weak breathing.

Do not use this medicine if you or your child are in any of the above situations. If you are unsure, consult your doctor or pharmacist before using Fendivia.

Warnings and precautions

Fendivia can cause life-threatening adverse effects in people who are not regularly using prescribed opioids.
Fendivia is a medicine that could be life-threatening to children, even if the patches have already been used. Note that a patch (used or unused) may be attractive to a child, and if it adheres to a child's skin or if the child puts it in their mouth, the result could be fatal.
Store this medicine in a safe and secure place, out of reach of others; see section 5 for more information.

If the patch adheres to another person

The patch must only be used on the skin of the person for whom the doctor has prescribed it. There have been cases where the patch has accidentally adhered to another family member due to close physical contact or sharing the same bed with the person wearing the patch. If the patch accidentally adheres to another person (particularly a child), the medicine from the patch can pass through the other person’s skin and may cause serious adverse effects, such as difficulty breathing, slow or weak breathing, which could be fatal. If the patch adheres to another person’s skin, remove it immediately and seek medical help.

Take special care with Fendivia

Consult your doctor or pharmacist before using this medicine if you are in any of the following situations. Your doctor will need to monitor you more closely:

If you have ever had lung or breathing problems.
If you have ever had heart, liver, or kidney problems, or low blood pressure.
If you have ever had a brain tumor.
If you have ever had persistent headaches or a head injury.
If you are elderly, as you may be more sensitive to the effects of this medicine.
If you have a disorder called "myasthenia gravis," in which muscles become weak and tire easily.

If you have any of the above conditions (or are unsure), consult your doctor or pharmacist before using Fendivia.

While using the patch, inform your doctor if you have breathing problems during sleep.

Opioids such as Fendivia can cause sleep-related breathing disorders, such as sleep apnea (interruptions in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood). Inform your doctor if you, your partner, or caregiver notice any of the following symptoms:

Pauses in breathing during sleep.
Waking up at night due to difficulty breathing.
Difficulty staying asleep.
Excessive daytime sleepiness.

Your doctor may decide to adjust your dose.

While using the patch, inform your doctor if you notice a change in your pain. If you experience:

Pain is no longer relieved by the patch.
An increase in pain.
A change in how you feel pain (e.g., pain in another part of your body).
Pain when something touches your body that you would not expect to cause pain.

Do not change the dose yourself. Your doctor may decide to adjust your dose or treatment.

Adverse effects and Fendivia

Fendivia may cause unusual drowsiness and may slow or weaken your breathing. Very rarely, these breathing problems can be life-threatening or even fatal, especially in people who have not previously used strong opioid painkillers (such as Fendivia or morphine). If you, your partner, or caregiver notice that the person wearing the patch is unusually drowsy, with slow or weak breathing:
Remove the patch.
Call a doctor or go immediately to the nearest hospital.
Encourage the person to move and speak as much as possible.
If you develop a fever while using Fendivia, speak to your doctor. This may increase the amount of medicine passing through your skin.
Fendivia may cause constipation; speak to your doctor or pharmacist for advice on how to prevent or relieve constipation.

The complete list of possible adverse effects can be found in section 4.

While wearing the patch, do not expose it to direct heat, such as heating pads, electric blankets, hot water bottles, heated water beds, or heat or tanning lamps. Do not sunbathe, take prolonged hot baths, or use saunas or hot tubs. Doing so may increase the amount of medicine released from the patch.

Long-term use and tolerance

This medicine contains fentanyl, an opioid. Repeated use of opioid painkillers may make the medicine less effective (the body becomes accustomed to it, known as pharmacological tolerance). You may also become more sensitive to pain while using Fendivia. This is known as hyperalgesia. Increasing the patch dose may continue to reduce pain for a time, but it may also be harmful. If you notice that the medicine is losing effectiveness, consult your doctor. Your doctor will decide whether it is better to increase the dose or gradually reduce the use of Fendivia.

Dependence and addiction

This medicine contains fentanyl, which is an opioid. It may cause dependence and/or addiction.

Repeated use of Fendivia may also lead to dependence, abuse, and addiction, which could result in a potentially fatal overdose. The risk of these adverse effects may be higher with higher doses and prolonged use. Dependence or addiction may cause a feeling of lack of control over the amount of medicine you need to use or how often you need to use it. You may feel the need to continue using the medicine even if it does not help relieve pain.

The risk of dependence or addiction varies from person to person. The risk of becoming dependent on or addicted to Fendivia may be higher if:

You or a family member has ever abused or been dependent on alcohol, prescription medicines, or illegal drugs ("addiction").
You are a smoker.
You have ever had mood disorders (depression, anxiety, or a personality disorder) or have been treated by a psychiatrist for a mental illness.

If you notice any of the following symptoms while using Fendivia, it could be a sign of dependence or addiction:

You need to use the medicine for longer than prescribed by your doctor.
You need to use a higher dose than recommended.
You are using the medicine for reasons other than prescribed, e.g., "to stay calm" or "to help you sleep."
You have made repeated unsuccessful attempts to stop using the medicine or control its use.
You feel unwell when you stop using the medicine, and feel better once you start again ("withdrawal effects").

If you notice any of these signs, consult your doctor to determine the best treatment approach for you, when it is appropriate to stop the medicine, and how to do so safely.

Withdrawal symptoms when stopping Fendivia

Do not stop using this medicine suddenly. Withdrawal symptoms may occur, such as restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased high blood pressure, nausea, vomiting, diarrhea, loss of appetite, tremors, chills, shaking, or sweating. If you wish to stop using this medicine, speak to your doctor first. Your doctor will advise you on how to do this, usually by gradually reducing the dose to minimize unpleasant withdrawal symptoms.

Using Fendivia with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines. This includes medicines purchased without a prescription and herbal remedies. You should also inform your pharmacist that you are using Fendivia if you buy any medicine at the pharmacy.

Your doctor will know which medicines can be safely used with Fendivia. You may need to be monitored closely if you are using or stop using any of the following types of medicines, as this may affect the dose of Fendivia you need.

In particular, inform your doctor or pharmacist if you are using:

Other pain medicines, such as other opioid analgesics (e.g., buprenorphine, nalbuphine, or pentazocine) and some analgesics for neuropathic pain (gabapentin and pregabalin).
Medicines to help you sleep (such as temazepam, zaleplon, or zolpidem).
Medicines to help you calm down (tranquilizers, such as alprazolam, clonazepam, diazepam, hydroxyzine, or lorazepam) and medicines for mental disorders (antipsychotics, such as aripiprazole, haloperidol, olanzapine, risperidone, or phenothiazines).
Medicines to relax muscles (such as cyclobenzaprine or diazepam).
Some medicines used to treat depression called SSRIs or SNRIs (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, or venlafaxine). – more information below.
Some medicines used to treat depression or Parkinson’s disease called MAOIs (such as isocarboxazid, phenelzine, selegiline, or tranylcypromine). You must not use Fendivia within 14 days of stopping these medicines. – more information below.
Some antihistamines, especially those that cause drowsiness (such as chlorpheniramine, clemastine, cyproheptadine, diphenhydramine, or hydroxyzine).
Some antibiotics used to treat infections (such as erythromycin or clarithromycin).
Medicines used to treat fungal infections (such as itraconazole, ketoconazole, fluconazole, or voriconazole).
Medicines used to treat HIV infection (such as ritonavir).
Medicines used to treat irregular heartbeats (such as amiodarone, diltiazem, or verapamil).
Medicines used to treat tuberculosis (such as rifampicin).
Some medicines used to treat epilepsy (such as carbamazepine, phenobarbital, or phenytoin).
Some medicines used to treat nausea or dizziness (such as phenothiazines).
Some medicines used to treat heartburn or ulcers (such as cimetidine).
Some medicines used to treat angina (chest pain) or high blood pressure (such as nicardipine).
Some medicines used to treat blood cancer (such as idelalisib).

Using Fendivia with antidepressants

The risk of adverse effects increases if you are using medicines such as certain antidepressants. Fendivia may interact with these medicines, and you may experience changes in mental state such as agitation, seeing, feeling, hearing, or smelling things that are not present (hallucinations), and other effects such as changes in blood pressure, rapid heartbeat, high body temperature, hyperactive reflexes, lack of coordination, muscle rigidity, nausea, vomiting, and diarrhea (these may be signs of serotonin syndrome). If used together, your doctor may want to monitor you closely for such adverse effects, especially when starting treatment or changing the dose of your medicine.

Using Fendivia with central nervous system depressants, including alcohol and some narcotics

Concomitant use of Fendivia and sedative medicines, such as benzodiazepines or related medicines, increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and may be life-threatening. Therefore, concomitant use should only be considered when no other treatment alternatives are available.

However, if your doctor has prescribed Fendivia and sedative medicines simultaneously, the dose and duration of treatment should be limited by your doctor.

Inform your doctor of all sedative medicines you are using, and follow the dose recommended by your doctor.

It may be helpful to inform your family and friends of the signs and symptoms mentioned above. Speak to your doctor if you experience any of these symptoms.

Use in athletes

Athletes are advised that this medicine contains a component that may result in a positive doping test.

Surgery

If you are scheduled to receive anesthesia, inform your doctor or dentist that you are using Fendivia.

Using Fendivia with alcohol

Do not drink alcohol while using Fendivia, unless you have discussed it with your doctor first.

Fendivia may cause drowsiness or slow breathing. Drinking alcohol may worsen these effects.

Pregnancy and breastfeeding

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

Fendivia should not be used during pregnancy unless you have discussed it with your doctor.

Fendivia should not be used during labor, as the medicine may affect the newborn’s breathing.

Prolonged use of Fendivia during pregnancy may cause withdrawal symptoms (such as high-pitched crying, irritability, seizures, poor feeding, and diarrhea) in your newborn baby, which may be life-threatening if not recognized and treated. Speak to a doctor immediately if you think your baby may have withdrawal symptoms.

Do not use Fendivia if you are breastfeeding. You must not breastfeed for 3 days after removing the Fendivia patch. This is because the medicine may pass into breast milk.

Driving and using machines

Fendivia may affect your ability to drive and use machines or tools, as it may cause drowsiness or dizziness. If so, do not drive or operate tools or machinery. Do not drive while using this medicine until you know how it affects you.

Speak to your doctor or pharmacist if you have any doubts about whether it is safe for you to drive while using this medicine.

3. How to use Fendivia

Follow exactly the instructions for administration of this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again.

Your doctor will decide which concentration of Fendivia is most suitable for you, taking into account the intensity of your pain, your general condition, and the type of pain treatment you have received so far.

Before starting treatment and regularly during treatment, your doctor will also explain to you what you can expect from using Fendivia, when and for how long you should use it, when you should contact your doctor, and when you should stop using it (see also section 2, withdrawal symptoms when you stop using Fendivia).

How to apply and change the patches

Each patch contains enough medicine for 3 days (72 hours).
You must change the patch every three days, unless your doctor has instructed otherwise.
Always remove the used patch before applying a new one.
Change the patch always at the same time of day every 3 days (72 hours).
If you are using more than one patch, change all of them at the same time.
Record the day of the week, date, and time each time you apply a patch, so you remember when to change it.
The table below shows when you should change the patch:

Apply the patch on		Change the patch on
Monday		Thursday
Tuesday		Friday
Wednesday		Saturday
Thursday		Sunday
Friday		Monday
Saturday		Tuesday
Sunday		Wednesday

Where to apply the patch

Adults

Apply the patch to a flat area of the trunk or arm (never over a joint).

Children

Always apply the patch to the upper back so that your child has difficulty reaching or removing it.
Check periodically to ensure the patch remains adhered to the skin.
It is important that the child does not remove the patch and put it in their mouth, as this could be life-threatening or fatal.
Closely monitor your child for 48 hours after:
- Applying the first patch
- Applying a patch with a higher dose
The patch may take some time to reach its full effect. Therefore, your child may require additional painkillers until the patch becomes effective. Your doctor will advise you accordingly.

Adults and children:

Do not apply the patch to

The same site twice in succession.
Areas that move a lot (joints), or to irritated or wounded skin.
Hairy skin areas. If hair is present, do not shave it (shaving may irritate the skin). Instead, cut the hair as close to the skin as possible.

How to apply the patch

Step 1: Prepare the skin

Before applying the patch, ensure the skin is completely dry, clean, and cool.
If washing is needed, use only cool water.
Do not use soap or other cleansers, creams, moisturizers, oils, or talcum powder before applying the patch.
Do not apply the patch immediately after a hot bath or shower.

Step 2: Open the pouch

Each patch is sealed in its own pouch.
Open the pouch by cutting along the dotted line with scissors.
Carefully cut the entire edge of the pouch to avoid damaging the patch inside.

Technical drawing showing a hand cutting a wrapper with scissors and a second hand opening the container by bending it backwards

Hold the two parts of the opened pouch and pull them apart.
Remove the patch and use it immediately.
Keep the empty pouch to dispose of the used patch later.
Use each patch only once.
Do not remove the patch from its pouch until you are ready to use it.
Check that the patch is not damaged.
Do not use the patch if it is split, cut, or otherwise damaged.
Never divide or cut the patch.

Step 3: Peel and press

Make sure the patch will be covered by loose clothing and do not apply it under elastic or tight fabric.
Carefully peel off half of the shiny plastic protective layer, starting from the center of the patch. Avoid touching the adhesive side of the patch.
Press this adhesive part of the patch onto the skin.
Remove the remaining protective layer and press the entire patch onto the skin with the palm of your hand.
Hold pressure for at least 30 seconds. Ensure the patch is well adhered, especially around the edges.

Step 4: Disposing of the patch

Immediately after removing the patch, fold it in half with the adhesive side folded onto itself.
Place it back into the original pouch and dispose of it according to your pharmacist's instructions.
Keep used patches out of sight and reach of children; even when used, patches contain medication that could harm children and may even be fatal.

Step 5: Washing hands

Always wash your hands with water only after handling patches.

More information on using Fendivia

Daily activities while using patches

Patches are water-resistant.
You may shower or bathe with the patch on, but do not rub it.
With your doctor's approval, you may exercise or engage in sports while wearing the patch.
You may also swim with the patch on, but:
- Do not use hot tubs or whirlpool baths.
- Do not cover the patch with elastic or tight bandages.
While wearing the patch, do not expose it to direct heat sources such as heating pads, electric blankets, hot water bottles, heated water beds, or heat or tanning lamps. Avoid prolonged sun exposure, hot baths, and saunas. Exposure to heat may increase the amount of medication released from the patch.

How long do the patches take to work?

The first patch may take some time to reach its full effect.
Your doctor may also prescribe additional painkillers during the first few days.
Afterwards, the patch should provide continuous pain relief, allowing you to stop taking other painkillers. However, your doctor may occasionally prescribe additional painkillers.

How long will you need to use the patches?

Fendivia patches are indicated for long-term pain. Your doctor will advise you on how long you can expect to use the patches.

If pain worsens

If your pain suddenly worsens after applying the latest patch, check the patch. If it is no longer adhering properly or has detached, replace it (see also the section If the patch comes off).
If your pain worsens over time while using the patches, your doctor may try patches with a higher dose or prescribe additional painkillers (or both).
If increasing the patch dose does not help, your doctor may decide to discontinue the patches.

If you use too many patches or a patch with the wrong dose

If you have applied too many patches or a patch with the wrong dose, remove them immediately and contact your doctor, go to a hospital, or call the Toxicology Information Service at 91 562 04 20, stating the medication and amount applied.

Signs of overdose include difficulty breathing or weak breathing, fatigue, extreme drowsiness, inability to think clearly or to walk or speak normally, dizziness, confusion, or lightheadedness. An overdose may also cause a brain disorder known as toxic leukoencephalopathy.

If you forget to change the patch

If you forget to change the patch, do so as soon as you remember, and note the date and time. Resume changing the patch every 3 days (72 hours) as usual.
If the delay is significant, speak to your doctor, as you may need additional painkillers, but do not apply extra patches.

If the patch comes off

If the patch falls off before it is time to change it, apply a new one immediately and note the date and time. Choose a new skin site:
- On the trunk or arm
- On the upper back of your child
Inform your doctor and keep the patch on for another 3 days (72 hours) or for the duration your doctor specifies, before changing the patch as usual.
If patches tend to fall off frequently, consult your doctor, pharmacist, or nurse.

If you want to stop using the patches

Do not stop using this medication suddenly. If you wish to discontinue this medication, speak to your doctor first. Your doctor will guide you on how to do so, usually by gradually reducing the dose to minimize withdrawal effects. See also section 2 "Withdrawal symptoms when stopping Fendivia".
If you stop using the patches, do not restart without first consulting your doctor. You may require a different dose when resuming treatment.

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.

If you, or your partner or caregiver, observe any of the following signs in the person wearing the patch, remove the patch immediately and contact a doctor or go straight to the nearest hospital. Urgent medical treatment may be required.

Unusual drowsiness, slower or weaker breathing than expected.

Follow the above recommendations and encourage the person wearing the patch to move and speak as much as possible. In very rare cases, these breathing difficulties can be life-threatening or even fatal, especially in people who have not previously used strong opioid analgesics (such as Fendivia or morphine). (Uncommon: may affect up to 1 in 100 patients).

Sudden swelling of the face or throat, severe irritation, redness, or blisters on the skin.

All of these may be signs of a severe allergic reaction. (Frequency cannot be estimated from available data).

Seizures (convulsions). (Uncommon: may affect up to 1 in 100 people).
Decreased level of consciousness or loss of consciousness. (Uncommon: may affect up to 1 in 100 people).

The following adverse effects have also been reported

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

Nausea, vomiting, constipation
Feeling sleepy (drowsiness)
Feeling dizzy
Headache

Common (may affect up to 1 in 10 people)

Allergic reaction
Loss of appetite
Difficulty sleeping
Depression
Feeling anxious or confused
Seeing, feeling, hearing, or smelling things that are not present (hallucinations)
Tremors or muscle spasms
Tingling or prickling sensation in the skin (paresthesia)
Sensation of spinning (vertigo)
Rapid or irregular heartbeat (palpitations, tachycardia)
High blood pressure
Shortness of breath (dyspnea)
Diarrhea
Dry mouth
Stomach pain or indigestion
Excessive sweating
Itching, rash, or redness of the skin
Inability to urinate or completely empty the bladder
Severe tiredness, weakness, or general malaise
Feeling cold
Swelling of the hands, ankles, or feet (peripheral edema)

Uncommon (may affect up to 1 in 100 people)

Feeling restless or disoriented
Feeling extremely happy (euphoria)
Decreased sensation or sensitivity, especially in the skin (hypoesthesia)
Memory loss
Blurred vision
Slow heart rate (bradycardia) or low blood pressure
Bluish discoloration of the skin due to reduced oxygen in the blood (cyanosis)
Loss of intestinal contractions (ileus)
Itchy skin rash (eczema), allergic reaction, or other skin disorders at the application site
Flu-like illness
Sensation of body temperature changes
Fever
Muscle cramps
Difficulty achieving or maintaining an erection (impotence) or problems with sexual performance
Difficulty swallowing

Rare adverse effects (may affect up to 1 in 1000 people)

Constriction of the pupils (miosis)
Occasional interruption of breathing (apnea)

Frequency not known (cannot be estimated from available data)

Lack of male sex hormones (androgen deficiency)
Delirium (symptoms may include a combination of restlessness, agitation, disorientation, confusion, fear, seeing or hearing things that are not real, sleep disturbances, nightmares)
You may become dependent on Fendivia (see section 2).

You may experience skin rashes, redness, or mild itching at the application site. These are usually mild and disappear after removing the patch. If they do not resolve, or if the patch causes significant skin irritation, inform your doctor.

Repeated use of the patches may cause the medicine to lose effectiveness (you may become accustomed to it or become more sensitive to pain), or you may become dependent.

If you switch from another painkiller to Fendivia, or if you stop using Fendivia suddenly, you may experience withdrawal symptoms such as dizziness, feeling unwell, diarrhea, anxiety, or tremors. Inform your doctor if you notice any of these effects.

Cases have also been reported in newborn infants who experienced withdrawal symptoms after their mothers used Fendivia for a prolonged period during pregnancy.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Fendivia

Where to store the patches

Keep all patches (used and unused) out of the sight and reach of children.

Store this medicine in a safe and secure place, where others cannot access it. It may cause serious harm or even death to individuals who accidentally or intentionally use this medicine when it has not been prescribed for them.

How long can you keep Fendivia

Do not use this medicine after the expiry date stated on the carton and on the pouch after EXP. The expiry date refers to the last day of the month indicated. If the patches have expired, take them to a pharmacy.

How to dispose of used or unused patches

Accidental exposure of other individuals, especially children, to used or unused patches may result in a fatal outcome.

Used patches should be folded firmly in half so that the adhesive side sticks to itself. They should then be safely discarded by placing them back into the original pouch and keeping them out of sight and reach of others, especially children, until they can be safely disposed of.

Medicines must not be disposed of via wastewater or household waste. Return any unused medicines and empty containers to a SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.

6. Contents of the container and other information

Composition of Fendivia

The active substance is: Fentanyl.

The patches are available in 5 different doses (see table below).

Name of the patch	Each patch contains:	Each patch releases a dose of:	The active surface area of each patch is:
Fendivia 12 micrograms/hour transdermal patch	1.38 mg	12 micrograms/hour	4.2 cm²
Fendivia 25 micrograms/hour transdermal patch	2.75 mg	25 micrograms/hour	8.4 cm²
Fendivia 50 micrograms/hour transdermal patch	5.5 mg	50 micrograms/hour	16.8 cm²
Fendivia 75 micrograms/hour transdermal patch	8.25 mg	75 micrograms/hour	25.2 cm²
Fendivia 100 micrograms/hour transdermal patch	11 mg	100 micrograms/hour	33.6 cm²

The other components are: dipropylene glycol, hydroxypropyl cellulose, dimethicone, silicone adhesive (amine-resistant), ethylene vinyl acetate (EVA, release membrane), polyethylene terephthalate (PET, outer plastic film), fluoropolymer-coated polyester (protective liner) and printing ink.

Appearance of the product and contents of the pack

Fendivia is a transparent, rectangular transdermal patch. Each patch is contained in a heat-sealed, child-resistant pouch made of paper, aluminium and polyethylene terephthalate (PET).

Each transdermal patch is printed in a specific colour with the brand name, active ingredient and dose:

Fendivia 12 micrograms/hour: brown printing
Fendivia 25 micrograms/hour: red printing
Fendivia 50 micrograms/hour: green printing
Fendivia 75 micrograms/hour: light blue printing
Fendivia 100 micrograms/hour: grey printing

The patches are supplied in cardboard packs containing 1, 3, 5, 10 and 20 patches. Only some pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

ISTITUTO GENTILI S.r.l.
Via San Giuseppe Cottolengo 15
20143 Milan, Italy

Manufacturer:

LTS Lohmann Therapie-Systeme AG
Lohmannstrasse 2D – 56626 Andernach
Germany

For further information about this medicinal product, contact the local representative of the Marketing Authorisation Holder:

Local representative:

FERRER FARMA, S.A.
Av. Diagonal, 549, 5th Floor,
08029 Barcelona (Spain)

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

Matrifen: Cyprus
Quatrofen: Sweden
Fendivia: Spain

Date of latest revision of the leaflet: 12-06-2024

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/