4 mg tablets 
reboxetine

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What Edronax is and what it is used for 
2. What you need to know before taking Edronax 
3. How to take Edronax 
4. Possible side effects 
5. How to store Edronax 
6. Contents of the packaging and other information 

1. What Edronax is and what it is used for

The active substance in Edronax is reboxetine which belongs to a group of medicines called antidepressants. Edronax is used for acute treatment of major depression and for maintaining the improvement of your symptoms when you initially respond to treatment with reboxetine.

2. What you need to know before you take Edronax

Do not take Edronax

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

Warnings and cautions

Talk to your doctor or pharmacist before taking Edronax if you:

  • suffering from seizures or epilepsy. Treatment with Edronax should be discontinued if seizures occur.
  • have symptoms of urinary tract problems, enlarged prostate, or previously had heart problems.
  • Taking medications to lower your blood pressure.
  • have liver or kidney problems. Your doctor may need to adjust dose one.
  • take other antidepressants such as MAO inhibitors, tricyclic antidepressants, nefazodone, SSRIs (such as fluvoxamine), or lithium.
  • take other MAOIs such as linezolid (an antibiotic ) or methylene blue (see section “Other medicines and Edronax”)
  • previously had mania (overactive behavior or thoughts).
  • have eye problems such as certain types of glaucoma (increased pressure in the eye)

If you start to feel worse and have thoughts of harming yourself.

You who are depressed and/or suffer from worry/anxiety may sometimes have thoughts of harming yourself or committing suicide. These symptoms may worsen when you start using antidepressants, as it takes time for this type of medicine to take effect, usually about 2 weeks, sometimes longer.

These thoughts may be common:

  • if you have previously had thoughts of harming yourself or committing suicide
  • if you are younger than 25 years. Studies have shown that young adults (younger than 25 years) with mental illness who are treated with antidepressant drugs have an increased risk of suicidal thoughts and thoughts of harming themselves.

Contact a doctor as soon as possible or see the nearest hospital if you have thoughts of injuring yourself or committing suicide.

It may be helpful to tell a relative or close friend that you are depressed and/or suffering from anxiety. Feel free to ask them to read this leaflet. You can also ask them to tell you if they think you are feeling worse or if they think your behavior is changing.

Children and young people

Edronax should not normally be used in the treatment of children and adolescents under 18 years of age. The risk of side effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, defiance, and anger) is greater in patients under 18 years of age when taking drugs of this type. Despite this, Edronax can be prescribed by a doctor to patients under 18 years of age, if the doctor deems it appropriate. If you are under 18 years of age and want to discuss why you were given this medicine, consult your doctor again.

You should also tell your doctor if you notice any of the above symptoms or if they get worse.

The long-term effects on growth, maturity, and cognitive and behavioral development have not yet been established for children and adolescents under 18 years of age.

Other medicines and Edronax

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Edronax may affect or be affected by other medicines. These include:

  • Some medicines for fungal infections, e.g. ketoconazole
  • Some antibiotics, e.g. erythromycin, rifampicin
  • Drugs called ergotamines and used to treat migraines or Parkinson’s disease
  • Some antidepressants called MAO inhibitors, tricyclic antidepressants, nefazodone, SSRIs (such as fluvoxamine), or lithium
  • Other MAOIs such as linezolid (an antibiotic ) or methylene blue (used to treat high levels of methemoglobin in the blood)
  • Diuretics , (non-potassium-sparing diuretics ) e.g. thiazide is
  • Drugs used to treat epilepsy e.g. phenobarbital, carbamazepine, phenytoin
  • An herbal medicine containing St. John’s wort (Hypericum perforatum)

Your doctor will decide if you can take Edronax with other medicines. Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, herbal medicines, or vitamins and minerals.

Edronax with food, drink, and alcohol

Edronax can be taken independently of food intake.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

There are no relevant data from the use of Edronax in pregnant women. Do not take Edronax if you are pregnant unless your doctor has made a careful assessment of the risk/benefit and has determined that it is necessary. Tell your doctor immediately if you are or are planning to become pregnant.

Breast-feeding

Small amounts of Edronax are excreted in human milk. There is a risk of a potential effect on the child. You should therefore discuss the issue with your doctor and he or she will decide if you should stop breast-feeding or stop taking Edronax.

Driving and using machines

Caution is advised when driving and operating machines.

You should not drive or use machines until you know that it is safe and that you are not affected by Edronax (ie you feel sleepy).

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

3. How to take Edronax

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

  • The recommended dose for adults is 8 mg per day (1 tablet of 4 mg twice daily). Depending on how you respond to the medication, your doctor may ask you to take 10 mg per day after three to four weeks, if necessary. The maximum daily dose should not exceed 12 mg.
  • In patients with renal or hepatic impairment, the starting dose is 4 mg per day. This dose may be increased depending on individual response.
  • The use of Edronax is not recommended for elderly patients.
  • Edronax should not be used by children and adolescents under 18 years of age.

The tablets should be taken on two occasions; one dose in the morning and one dose in the evening. You should swallow the tablets with a glass of water. The tablet can be divided into two equal doses. Do not chew the tablets. To help you remember to take Edronax, it may be a good idea to take the tablets at the same time each day.

Like other medicines, Edronax will not relieve your symptoms immediately. You should feel better within a couple of weeks.

You must continue to take your tablets, even if you feel better until your doctor advises you to stop. Try to be patient, if you stop taking the tablets too soon, your symptoms may return.

If you take more Edronax then you should

If you have ingested too much medicine or if e.g. If a child has accidentally ingested the medicine, contact a doctor, hospital, or the Poison Information Center immediately for risk assessment and advice. You should never take more tablets than your doctor recommends. If you take more Edronax than you should, you may experience symptoms of overdose such as low blood pressure, anxiety, and high blood pressure.

If you forget to take Edronax

If you forget to take Edronax, take the next dose at the usual time Do not take a double dose to make up for a forgotten dose.

If you stop taking Edronax

You should not stop taking your medicine without talking to your doctor as the symptoms may return.

There are a few reports of withdrawal symptoms that include headaches, dizziness, nervousness, and nausea when patients have discontinued treatment with Edronax.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Most side effects of Edronax are mild and resolve after a couple of weeks of treatment.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

A very common side effect is (occurring in more than 1 in 10)

  • Difficulty sleeping (insomnia)
  • Dizziness
  • Dry mouth
  • Constipation
  • Nausea
  • Sweating

Common adverse s (less than 1 in 10)

  • Headache
  • Lack or loss of appetite
  • Restlessness, anxiety
  • Paresthesia (ant crawling), difficulty sitting or standing still, altered taste perception
  • Inability to focus vision
  • Increased heart rate, palpitation (palpitations)
  • Dilation of blood vessels, drop in blood pressure when getting up quickly, high blood pressure
  • Vomiting
  • Rash
  • Feeling of not being able to empty the bladder, extra slow emptying, urinary tract infection, pain when urinating, inability to empty the bladder completely
  • Erectile dysfunction ( impotence ), pain during ejaculation, delayed ejaculation
  • Overindulge

Less common side effects are (between 1 and 10 in 1000)

  • Dilated pupils are
  • Dizziness

Rare side effects are (between 1 and 10 in 10,000)

  • Glaucoma (a condition that causes increased pressure in the eye)

Following the marketing of reboxetine, the following adverse reactions have been reported:

  • Hyponatremia (very low levels of sodium in the blood)
  • Aggression, hallucinations
  • Suicidal thoughts and suicidal behavior cases of suicidal ideation and behavior have been reported during treatment with reboxetine or immediately after stopping treatment (see section 2 “Warnings and precautions”) 
  • Cold hands and feet, Raynaud’s phenomenon (poor blood circulation in the extremities usually in the toes and fingers but can also affect the nose and ears, the skin becomes pale, cold, and numb),
  • Allergic inflammation of the skin
  • Testicular pain
  • Irritability
  • Increased pressure in the eye

5. How to store Edronax

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

Do not use this medicine after the expiry date which is stated on the carton or jar. The expiration date is the last day of the specified month.

  • Do not store above 25

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is reboxetine. Each tablet contains 4 mg of reboxetine.
  • The other ingredients are microcrystalline cellulose, dibasic calcium phosphate dihydrate, crospovidone, colloidal aqueous silica, and magnesium stearate.

What the medicine looks like and the contents of the pack

Edronax 4 mg are white, round, convex tablets with a scoreline. The tablet is marked “P” on the left and “U” on the right side of the breaker notch. On the side without a break, the tablet is marked “7671”. The tablet can be divided into two equal parts.

The tablets are supplied in packs containing 10, 20, 50, 60, 100, 120, or 180 tablets in pressure packs, 60 tablets in glass jars, multi-packs of 3×60, 5×60, and 10×60 tablets in pressure packs and 3×60, 5×60, and 10×60 tablets in glass jars.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Pfizer AB 
191 90 Sollentuna

Tel: 08-550 520 00

Email: eumedinfo@pfizer.com

Manufacturer

Pfizer Italia Srl

63100 Localita, Marino Del Tronto

Ascoli Piceno

Italy

This medicine is approved under the name Edronax in Belgium, Denmark, Finland, Ireland, Italy, Luxembourg, Portugal, Great Britain, Germany, and Austria. It is also approved in Spain under the name Norebox.

Muhammad Nadeem

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