GARDENALE 100 mg Tablets

Зміст інструкції

1. Gardenale 50 mg tablets, 100 mg tablets
   1. What is Gardenale and what is it used for
   2. What you need to know before taking Gardenale
   3. How to take Gardenale
   4. Possible side effects
   5. How to store Gardenale
   6. Contents of the pack and other information

Gardenale 50 mg tablets, 100 mg tablets

phenobarbital

Read this leaflet carefully before taking this medicine as it contains
important information for you.

• Keep this leaflet. 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 pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What is Gardenale and what is it used for

Gardenale contains phenobarbital, which belongs to a class of medicines called
"anticonvulsant barbiturates".
Gardenale is indicated in epilepsy, for treating violent and involuntary contractions of the
muscles called convulsions (in particular, tonic-clonic seizures of grand mal and
focal cortical seizures).
Gardenale can be used to detoxify from prolonged use of barbiturates
(chronic barbiturism).

2. What you need to know before taking Gardenale

Do not take Gardenale

• if you are allergic to phenobarbital, other barbiturates or any of the other ingredients of this medicine (listed in section 6);
• if you suffer from a blood disease called porphyria;
• if you have kidney or liver problems (renal or hepatic insufficiency);
• if you have serious heart problems (severe heart disease);
• if you have acute intoxication due to alcohol, medicines used to treat pain (analgesics), medicines used to help you sleep (hypnotics);
• if you are taking daclatasvir, dasabuvir, paritaprevir, ombitasvir, ledipasvir, sofosbuvir (medicines used against HIV and hepatitis C virus) (see "Other medicines and Gardenale").

medicines and Gardenale").

Warnings and precautions
It is important to read this section carefully if you are going to take this
medicine.
Consult your doctor or pharmacist before taking Gardenale.
Serious skin problems such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP) have been reported with Gardenale:

• The symptoms of SJS or TEN may include blisters, peeling or bleeding on any part of the skin (including lips, eyes, mouth, nose, genitals, hands or feet) with or without a rash. You may also have flu-like symptoms such as fever, chills or muscle pain.
• The symptoms and signs of DRESS may include flu-like symptoms and a widespread rash with high body temperature and swollen lymph nodes. Abnormal blood test results may include increased levels of liver enzymes and an increase in a type of white blood cells (eosinophilia) and swollen lymph nodes.
• The symptoms of AGEP appear early in treatment and may include a widespread red and scaly rash with blisters under the skin (including skin folds, chest, abdomen (including the stomach area), back and arms) and blisters accompanied by fever. The highest risk of developing serious skin reactions is in the first few weeks of treatment. If you develop serious skin reactions or any of the reactions listed above, contact your doctor or healthcare professional immediately. If you have developed Stevens-Johnson syndrome, toxic epidermal necrolysis or DRESS syndrome, with the use of medicines containing phenobarbital, you should no longer use the medicine.

Gardenale can cause habituation (decreased effectiveness).
Continued therapy may interfere with some medicines, for example, medicines used
to thin the blood (anticoagulants), some antibiotics, some medicines used
to treat inflammation (adrenal steroids), etc.
Your doctor will prescribe Gardenale with caution in combination with other medicines such
as those for treating psychiatric disorders (psychotropic drugs) and those used to treat allergies
(antihistamines).
Do not take St. John's Wort (Hypericum perforatum) preparations
at the same time as medicines containing phenobarbital, such as Gardenale, as St. John's Wort
may reduce their activity (see "Other medicines and Gardenale").
Do not abruptly stop treatment with Gardenale as, in patients with epilepsy,
seizures may occur.
Your doctor will prescribe a reduced dose of Gardenale if you have kidney problems
(renal insufficiency), liver (hepatic insufficiency), if you are elderly and if you have
alcohol problems.
Consumption of alcoholic beverages is still not recommended when taking this
medicine.
Thoughts of suicide may occur during treatment with antiepileptic medicines such as Gardenale.
Contact your doctor immediately whenever such thoughts occur.

Children and adolescents
If a child needs to be treated with Gardenale for a long time, the doctor will assess
the possibility of prescribing a medicine to prevent a bone disease
called rickets.

Other medicines and Gardenale
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
The effects of Gardenale may be affected by or affect the following medicines.
The combination of Gardenale and the following medicines is contraindicated:

• Daclatasvir, dasabuvir, paritaprevir, ombitasvir, ledipasvir, sofosbuvir (used against theHIV and hepatitis C virus),due to the possible decrease in their effectiveness.

The combination of Gardenale and the following medicines is not recommended:

• Estroprogestins and progestins (hormones used as contraceptives),as Gardenale decreases their contraceptive effectiveness. If you are taking Gardenale, you should use a different method of contraception such as a barrier contraceptive method (mechanical contraceptive) (see section “Pregnancy and breastfeeding”).
• St. John's Wort (Hypericum perforatum),as the action of Gardenale may be reduced by the simultaneous administration of St. John's Wort preparations and for at least two weeks after stopping taking such products. If you are taking St. John's Wort products at the same time as Gardenale, your doctor will perform checks, discontinue therapy with St. John's Wort products and may adjust the doses of Gardenale.

The combination of Gardenale and the following medicines requires particular caution (in some
cases your doctor may adjust the doses):

• Cyclosporine (used to prevent rejection in organ transplants),as Gardenale decreases its action.
• Corticosteroids(glucosteroid hormones, mineral-corticoid hormones,usedagainstinflammation, in some diseases such as Addison's disease and in transplants),as Gardenale decreases their action.
• Doxycycline (antibiotic).
• Saquinavir(antiretroviral medicine) as Gardenale may reduce its effectiveness.
• Hydroquinidine, quinidine (used to treat heart problems), as Gardenale

decreases their action.

• Levothyroxine (used for the thyroid),as your doctor may adjust the dosage.
• Theophylline and all derivatives of theophylline (used for asthma),as Gardenale decreases its action.
• Folic acid (used for anemia), as it decreases the action of Gardenale.
• Valproic acid (used for seizures),as it increases the action of Gardenale. Gardenale, in turn, decreases the action of valproic acid. See your doctor if you feel excessive calmness (sedation). Your doctor will have blood tests done to measure the concentrations of Gardenale and valproic acid in your blood. See your doctor if you experience nausea, vomiting, agitation, confusion, seizures, drowsiness, muscle coordination disorders (symptoms of hyperammonemia).
• Oral anticoagulants (used to thin the blood),as Gardenale decreases their action.
• Imipramine antidepressants (used for depression),as they promote the onset of seizures (generalized convulsive crises).
• Digitoxin (used to treat heart problems),as Gardenale decreases its action.
• Progabide (another medicine for epilepsy),as it increases the action of Gardenale.
• Carbamazepine (used for seizures),as Gardenale decreases its presence in the blood.
• Disopyramide (used to treat heart problems),as Gardenale decreases its action.
• Other medicines that act on the Central Nervous System (some antidepressants; most anti-H antihistamines, benzodiazepines, clonidine and similar medicines, hypnotics, morphine derivatives (analgesics and cough suppressants), neuroleptics, tranquilizers other than benzodiazepines),as Gardenale increases the effect of these medicines and this can have serious consequences, especially when driving or operating machinery.
• Phenytoin (used for seizures),as Gardenale may vary its amount in the blood.
• Alprenolol, metoprolol, propranolol (beta-blockers, used for the treatment ofhigh blood pressure and some heart diseases),as Gardenale decreases their action .

Other associations to be considered:

• Ritonavir, simeprevir, dolutegravir(used against HIV and hepatitis C virus),as Gardenale may decrease their action .
• Anticancer drugs,with the use of Gardenale and some anticancer drugs, a decrease in exposure to the latter is possible.
• Lamotrigine (used for epilepsy),possible decrease in the effectiveness of lamotrigine and reduction of some blood cells (leukopenia and thrombocytopenia).
• Amitriptyline/amitriptyline oxide (used for depression),possible decrease in their concentrations in the blood.
• Antithrombotics such as apixaban and ticagrelor(used to prevent blood clots)for the possible reduction of their effectiveness.
• Cenobamate, because it can increase the levels of phenobarbital in the blood and your doctormay adjust the dose.

Gardenale with food, drinks and alcohol
During treatment with Gardenale, avoid consuming alcoholic beverages.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking
this medicine.

Pregnancy
Gardenale is able to cross the placenta. If taken during pregnancy, the
phenobarbital may cause serious birth defects and may exert a delay in the development
of the child. Birth defects that have been reported in studies include cleft lip (split upper lip), cleft palate (split palate), heart and blood vessel anomalies,
muscle and bone malformations, and alterations to
the central nervous system. Other birth defects have also been reported, such as
penile malformations (hypospadias), head size smaller than normal, facial, nail and finger anomalies.
During pregnancy, your doctor will perform checks to detect any
malformations present in the fetus.
If you take phenobarbital during pregnancy, you have a greater risk than other
women of giving birth to a baby with birth defects that require medical care. In the
general population, the baseline risk of major malformations is 2-3%. This risk
increases by about 3 times in women who take phenobarbital.
Babies born to mothers who use phenobarbital during pregnancy may also have
an increased risk of being smaller than expected.
Neurological developmental disorders (delays in development due to
brain developmental disorders) have been reported in children exposed to phenobarbital during pregnancy.
Studies on the risk of neurological developmental disorders remain conflicting and however
the risk cannot be excluded.
If Gardenale is used in combination with other antiepileptic drugs, the risk of
adverse effects for the unborn child increases compared to the use of Gardenale alone.
Phenobarbital should not be used during pregnancy unless an equally effective therapeutic alternative is available.
Inform your doctor immediately if you are pregnant. The doctor should discuss the possible effects
of phenobarbital on the unborn child and carefully consider the risks and benefits of treatment.
Do not stop taking Gardenale until you have discussed it with your doctor,
as sudden discontinuation of the drug may increase the risk of developing
convulsions, which can have harmful effects on you and the unborn child.
If you have taken phenobarbital during the last three months of pregnancy, appropriate monitoring should be performed to detect potential disorders in the newborn, such as convulsions,
excessive crying, muscle weakness, sucking disorders.
Because Gardenale causes a decrease in the amount of a vitamin (folate),
your doctor will recommend taking folate both before and during pregnancy, even if
folic acid reduces the effects of Gardenale (see paragraph “Other medicines and
Gardenale”).

Women of childbearing potential/Contraception
If you are a woman of childbearing potential, you should use an effective method of contraception during
treatment with phenobarbital and for two months after treatment. Phenobarbital may
affect how hormonal contraceptives, such as the contraceptive pill, work
and make them less effective in preventing pregnancy. See your doctor who will discuss with you
the most suitable type of contraception to use while taking phenobarbital.
If you are a woman of childbearing potential and are planning a pregnancy, consult your doctor before
stopping contraception and before starting a pregnancy. Consult your doctor for
switching to other appropriate treatments, to avoid exposing the fetus to phenobarbital

Newborns
If you take Gardenale, the newborn may have severe bleeding (hemorrhagic syndrome). Your
doctor may prescribe vitamin K during the last month of pregnancy to prevent
this event.

Breastfeeding
The use of Gardenale during breastfeeding is not recommended because it is excreted into
breast milk.

Driving and operating machinery
Treatment with Gardenale reduces attention and lengthens reaction times. Keep this in
mind if you need to drive vehicles or operate machinery that requires a high level of
vigilance due to its danger.

3. How to take Gardenale

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is:
Adults
From 100 to 300 mg per day in 2-3 administrations;
Use in children
From 20 to 100 mg according to age and weight.
The tablets can be broken in a little water or possibly added to foods.
Use in the elderly
If you are elderly, your doctor will carefully establish the dosage and evaluate a possible
reduction of the dosages mentioned above.

If you take more Gardenale than you should
In case of accidental ingestion/administration of an excessive dose of Gardenale, immediately inform your doctor or go to the nearest hospital.
Shortly after taking a too high dose, the following may appear: nausea, vomiting, headache, confusion, coma accompanied by slowing of breathing, obstruction of the
trachea and bronchi, lowering of blood pressure.

If you forget to take Gardenale
Do not take a double dose to make up for the missed tablet.

If you stop taking GardenaleGardenale
If you have any doubts about the use of this medicine, consult your doctor or pharmacist; the
therapy should not be interrupted abruptly.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Contact your doctor or pharmacist if you have been taking an antiepileptic medicine for a long time, or if you have a history of osteoporosis, or if you are taking medicines called steroids.
If you have been treated with Gardenale during pregnancy, your baby (newborn) may experience, with unknown frequency, a blood coagulation disorder, characterized
by bleeding (hypoprothrombinemia).
For congenital malformations see paragraph “Pregnancy”.

Common side effects (may affect up to 1 in 10 people)

• skin allergies (in particular spots and papules resembling measles or scarlet fever),
• learning (cognitive) disorders,
• insufficient memory (memory deficit),
• abnormal behavior such as agitation and aggressiveness,
• nausea and vomiting,
• hand condition characterized by progressive and permanent flexion of one or more fingers (Dupuytren's contracture).

Uncommon side effects (may affect up to 1 in 100 people)

• loss of coordination of movements (ataxia) especially if you are elderly and take high doses of Gardenale,
• mood swings,
• sleep disorders/insomnia.

Rare side effects (may affect more than 1 in 1000 people)

• a disease characterized by one or more target-like lesions on the skin, with an appearance similar to a target (multiforme erythema),
• from spots on the skin caused by small skin bleeding (purpura),
• excitement, delirium,
• impaired attention.

Side effects with unknown frequency (frequency cannot be defined on the basis of available data)

• Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN), whose symptoms may include blisters, peeling or bleeding on any part of the skin (including lips, eyes, mouth, nose, genitals, hands or feet) with or without a rash. You may also have flu-like symptoms such as fever, chills or muscle pain,
• drug reaction with eosinophilia and systemic symptoms (DRESS), whose symptoms and signs may include flu-like symptoms and a widespread rash with high body temperature and swollen lymph nodes. Abnormal blood test results may include increased levels of liver enzymes and an increase in a type of white blood cells (eosinophilia) and swollen lymph nodes,
• acute generalized exanthematous pustulosis (AGEP), whose symptoms may include a widespread red and scaly rash with bumps under the skin (including skin folds, chest, abdomen (including the stomach area), back and arms) and blisters accompanied by fever at the beginning of treatment.
• severe and widespread redness with skin peeling (exfoliative dermatitis),
• redness of the skin with blisters due to the medicine (fixed eruption),
• liver inflammation (toxic hepatitis),
• disorders and decrease, even severe, of blood cells (neutropenia, pancytopenia, aplastic anemia),
• diseases characterized by a reduction of certain blood cells (leukopenia, agranulocytosis, thrombocytopenia),
• increase in the size of red blood cells (folate deficiency anemia) during long-term (chronic) treatments,
• lowering of the level of consciousness (sedation), involuntary eye movement (nystagmus), mental confusion, especially if you are elderly and take high doses of Gardenale,
• memory loss (amnesia),
• alteration of muscle movement (dyskinesia),
• in children, manifestations of hyperactivity may occur ,
• bone diseases, which may manifest as malformations, pain and fractures, such as osteomalacia (weakening of bone tissue), osteopenia and osteoporosis (thinning of the bones) during long-term (chronic) treatments.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet,
contact your doctor or pharmacist. You can also report side effects directly
through the national reporting system at
www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects
you can contribute to providing more information on the safety of this medicine.

5. How to store Gardenale

Do not store at a temperature above 30°C.
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after
“Exp.”. The expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Gardenale contains

Gardenale 50 mg tablets

• The active ingredient is phenobarbital. One tablet contains 50 mg of phenobarbital.
• The other ingredients are: corn starch, magnesium stearate, pregelatinized corn starch.

Gardenale 100 mg tablets

• The active ingredient is phenobarbital. One tablet contains 100 mg of phenobarbital.
• The other ingredients are: corn starch, magnesium stearate, pregelatinized corn starch.

Description of the appearance of Gardenale and contents of the pack
Gardenale is available in tablet form:

• 50 mg in a box of 30 tablets in blisters
• 100 mg in a box of 20 tablets in blisters.

Marketing Authorisation Holder
Atnahs Pharma Netherlands B.V.
Copenhagen Towers
Ørestads Boulevard 108, 5.tv
DK-2300 Copenhagen S
Denmark

Manufacturer
Sanofi S.r.l.
S.S. 17 km 22 – 67019 Scoppito (AQ)