Baclofen 10 – patient leaflet, side effects, dosage

What Baclofen is and what it is used for

The active substance in Baclofen 10 mg/5 ml solution for infusion is baclofen, which belongs to a group of medicines called muscle relaxants.

Baclofen is a medicine to relieve severe muscle spasms (antispastic).

Your doctor has decided that you or your child needs this medicine to help treat your condition.

Baclofen is intended for adults and children of 4 years and above and is used to reduce and relieve the excessive tension in your muscles (spasms) occurring in various illnesses such as cerebral palsy, multiple sclerosis, spinal cord diseases, cerebrovascular accidents, and other nervous system disorders.

Baclofen 10 mg/5 ml solution for infusion is used to treat severe chronic spasticity associated with multiple sclerosis, following spinal injuries or those of cerebral origin that are unresponsive to standard medical treatment.

For this purpose a special infusion pump is implanted under your skin which allows continuous delivery of small quantities of Baclofen 10

mg/5 ml solution for infusion into the spinal cord.

You will be monitored closely in a fully equipped and staffed environment during the screening phase and dose-titration period immediately following pump implant. You will regularly be assessed for your dosage requirements, for possible side effects or evidence of infection. The functioning of the delivery system will also be checked.

2. What you need to know before you or your child are given Baclofen

Do not use Baclofen

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

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if you have epilepsy that is untreatable.

Warnings and precautions

Talk to your doctor before you are given Baclofen if you

• slowed circulation of cerebrospinal fluid due to obstruction of flow
• have psychotic disorders and schizophrenia
• have cardiac problems
• are having any other injections into the spine
• are suffering from any infection
• have had a head injury within the last year
• have ever had a crisis caused by a condition called autonomic dysreflexia (your doctor will be able to explain this to you)

• neurological disorders caused by damage to the cranial nerves responsible for muscle

  function in the medulla

  • oblongata (bulbar paralytic disorders) or partial paralysis of the

    respiratory muscles

• have had a stroke
• have epilepsy or other cerebral seizures
• have a stomach ulcer or any other problem with your digestion
• suffer from any mental illness
• acute or chronic states of confusion
• are being treated for high blood pressure
• have Parkinson’s disease
• suffer from any liver, kidney or lung disease
• have diabetes
• have difficulties in urinating
• are pregnant or breastfeed.

For patients with spasticity due to head injury, it is recommended not to proceed to long-term Baclofen therapy until the symptoms of spasticity are stable and can be reliably assessed.

Tell your doctor immediately if you get any of these symptoms during treatment with Baclofen:

• if you have pain in your back, shoulders, neck and buttock during the treatment (a type of spinal deformity called scoliosis).

• if you have thoughts of harming or killing yourself at any time, speak to your doctor straight away or go to a hospital. Also, ask a relative or close friend to tell you if they are worried about any changes in your behaviour and ask them to read this leaflet.

  Children and adolescents

  Baclofen intrathecal formulation is intended for children of 4 years and above.

  Children should be of sufficient body mass to accommodate the implantable pump. There is very limited clinical data in children under the age of six. The safe use of Baclofen in the spinal cord of children under the age of four has not yet been established.

  Elderly

  Several patients over the age of 65

  years have been treated with Baclofen during the clinical trials without specific problems. Experience with baclofen tablets shows however that this patient group may be more susceptible to side effects. Elderly patients should therefore be carefully monitored for the occurrence of side effects

  Other medicines and Baclofen

  Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

  The following medicines may interact with Baclofen or Baclofen may interact with them:

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  other medicines for your spastic condition (for example tizanidine or diazepam)

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  medicines to treat your Parkinson’s disease

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  medicines to relieve severe muscle spasms (antispastics)

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  medicines that have depressant effects on the functions of the central nervous system

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  medicines to treat depression, like imipramine, doxeprine, amitryptyline, opipramol (tricyclic antidepressants)

  -

  medicines used to treat high blood pressure

  -

  opiates for pain relief (for example morphine).

  It may be necessary for the doctor to adjust the dose of Baclofen or one of your other medicines.

  Baclofen with food, drink and alcohol

  Drinking alcohol while using Baclofen should be avoided as this may lead to an undesirable intensification or unpredictable change in the effect of the medicine.

  Pregnancy,breast-feeding and fertility

  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.

  There is no experience on the use of Baclofen during pregnancy or while breast-feeding. Baclofen should not be used during pregnancy or while breast-feeding unless the expected benefit for the mother outweighs the potential risk for the child. Baclofen passes into breast milk. As so far there are no adequate studies available the concentration cannot be predicted.

  Driving and using machines

  Some people may feel drowsy and/or dizzy or have problems with their eyes while they are being treated with Baclofen. If this happens your ability to drive or operate machines may be considerably impaired.

  Do not drive, operate machines or participate in any other hazardous activities.

  In particular it should be noted that drinking alcohol at the same time further intensifies this decreased alertness.

  Baclofen 10 mg/5 ml contains sodium

  This medicine contains less than 1 mmol sodium (23 mg) per maximum dose of 1 ml (corresponding to 2 mg baclofen), that is to say essentially “sodium-free”.

3. How to use Baclofen

Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.

At a first stage the doctor will find out by single injections of Baclofen 0.05

mg/l ml if this improves your muscular spasms. The usual test dose is ½ to 1 ampoule. It may be increased by ½ ampoule at a time at 24-hour intervals to a maximum of 2 ampoules. You must be monitored for 4 to 8 hours after each injection.

If a significant improvement in muscular spams is possible, a special pump will be implanted under your skin, which permits continuous delivery of small quantities of Baclofen.

It may take several days to find out the optimal dose for you. Once the optimum treatment is established, your doctor must check your progress and functioning of the pump at regular intervals.

Intrathecal use.

Baclofen can be administered only by qualified specialist doctors by direct injection or infusion in the back (spinal cord), for which special medical equipment is needed. For this reason hospitalisation will be necessary at the beginning of therapy.

It is extremely important that you keep your appointments with the doctor to refill the pump, otherwise spasms may recur because you are not getting a high enough dose of Baclofen.

Your muscle spasms may worsen as a result.

If your muscle spasticity is not improving or if you start having spasms again, either gradually or suddenly, contact your doctor immediately.

If treatment with Baclofen is interrupted

It is very important that you, and those caring for you, are able to recognise signs of Baclofen withdrawal. These may appear suddenly or slowly for example because the pump is not working properly due to battery problems, catheter problems or alarm dysfunction. Get urgent medical

help if you observe that your implanted device is not working and you also notice withdrawal symptoms.

The signs of withdrawal are

• increased spasticity, too much muscle tone
• difficulty with muscle movements
• increase in heart rate or pulse
• itching, tingling
• burning sensation or numbness (paraesthesia) in your hands or feet
• palpitations

Bac_lo^fen 10

baclo^fen

The _fo_llow_ing _in_fo_rma_tion _is _in_tended ^fo^r hea^lthca^re p^ro^fessⁱona^ls on^ly^:

How _is Bac_lo_fen p_repared and admⁱnⁱs^te^red?

The sc_reen_ing_{, i}mp_lan_ta_tion and dose ^titra^tion phases o^{f t}he ⁱn^tra^theca^l _trea_tmen_t a_re _to be ca_rried ou^{t i}n hosp^ita^l w^ith ve^r y ca_re_fu_l mon^ito^ring by app_rop_ria_te_ly qua_lified spec_ia_lis^t doc^to^rs and ⁱn cen^tres w^ith spec^ific expe_rience_{. I}n v_iew o_f poss_ib_le _life-^th^rea^tenⁱng even^ts o^r seve^re adve^rse _reac_tions app_rop_ria_te _resusc_ita_tive equⁱpmen^t shou^ld be on s^tand^-by^{. (}see a_lso sec_tion 3 “How ^to Use Bac^lo^fen”^).

Es_tab_lishmen_t o_{f t}he op_timum dose schedu^le ^fo^r Bac^lo^fen ^requ^ires ^tha^t each pa_tien_t unde_rgoes an _in_itia_l sc_reening phase w^ith a bo^lus ⁱn^jec^tion o^f 0^.05 mg_/1 m_l Bac_lo_fen v_ia an _in_tra_theca_l cathe^te^r o^{r l}umba^r punc^tu^re^{, f}o^llowed by a ve^r y ca_re_fu_{l i}nd_iv_idua_l dose _titra_tion p^rio^{r t}o maⁱn^tenance ^the^rapy^. Thⁱs ⁱs necessa^r y because o_{f t}he g_rea_t va_riab_ility be^tween pa^tien^ts ⁱn ^the ^the^rapeu^tic dose _tha_{t i}s e_ffec_tive^. Du^ring ^long^-te^r m _trea_tmen_t bac_lofen can be de^live^red con_tinuous_ly _in_to _the ce_reb_ra_l sp_ina^{l fl}uⁱd usⁱng an ⁱmp^lan^tab^le pump and Bac_lo^fen 10

Ev_idence demons_tra_ting _the e_fficacy o_f Bac^lo^fen was ob^taⁱned ⁱn c^linⁱca^{l tri}a^ls us_ing _the Synch_roMed _In_fus_ion Sys^tem^. Thⁱs ⁱs an ⁱmp^lan^tab^le d^r ug delⁱve^r y sys_tem w_ith _ref^illab^le ^rese^r vo_irs_, wh_ich _is _imp_lan_ted ⁱn a subcu^taneous pocke^t usua_lly on _the abdom_ina_l wa_ll. The devⁱce ⁱs connec^ted ^to an ⁱn^tra^theca^l ca_the_te_{r t}ha_t passes subcu_taneous_ly ^to ^the suba^rachnoⁱd space^. Re^liab^le expe_rience w_ith o_the_{r i}mp_lan_tab_le pump sys^tems ⁱs so ^fa^r no^t ava^ilab^le^.

Be_fo_re us_ing Bac_lo_fen _in pa_tien_ts w^ith pos^ttrauma^tic spas^tic^ity ^the suba_rachno_id space shou_ld be _inves_tiga^ted usⁱng mye^log^raphy^{. If t}hⁱs ^revea^ls s_igns o_f an a_rachno_id_itis_{, tr}ea_tment w^ith Bac^lo^fen mus^t no^t be ⁱn^itia^ted^.

Be_fo_re us_ing Bac_lo_fen each so_lu_tion shou^ld be ^tes^ted ^to make su^re ^{it i}s c^lea^r and co_lou_rless^{; if} pa^r _ticu_la_te ma_tte_r o_r d_isco_lo_ratⁱons a^re p^resen^{t, t}he so^lu^tion mus_t no_t be used and shou^ld be dⁱsca^rded^.

Each ampou_le_/v_ia_{l i}s _fo_r s_ing_le use only^. The so^lu^tion ^it con^taⁱns ⁱs s^tab^le^, _iso_ton_ic_, py_rogen and an_tiox_idant ^free and has a pH^-va^lue o^f 5^.0–7^.0^.

Bac_lo^fen 10

_Imp_lan_ta_tion phase_/Dose _titra_tion phases ⁽unde^r hosp^ita^l cond^itions⁾

A^f _te_r con^fir ma_tion _tha_t Bac_lo_fen has been ef^fec^tive ⁱn ^the sc^reenⁱng phase^, _in_tra_theca_{l i}n_fus_ion _is es_tab_lished usⁱng ^the above^-men^tioned ⁱmp^lan^tab^le _in_fus_ion pump_. The onse_t o_{f t}he antⁱspas^tic e^ffec^t o^f bac^lo^fen ⁱs 6–8

a^f _te_r con_tinuous _in_fus_ion _is _in_itia_ted and ^the maxⁱmum e^ffec^{t i}s achⁱeved w^ithⁱn 24–48

The _in_itia_{l t}o_ta_l da_ily dose o_f Bac^lo^fen ⁱs ca^lcu^la^ted as ^fo^llows^:

_if e_fficacy o_{f t}he _tes_t dose is maⁱn^taⁱned ^fo^r mo^re ^than 12

adm_in_is_te_red as _the _in_itia_l da_ily dose^{. If t}he e^fficacy o^{f t}he ^tes^t dose ⁱs ma_in_ta_ined _fo^{r l}ess ^than 12

_the _in_itia_l da_ily dose_. No dose _inc_rease shou^ld be admⁱnⁱs^te^red ⁱn ^the ^firs^t 24

A^f _te_{r t}he _firs_t day o_{f tr}ea_tmen_{t t}he dose can be ad^jus^ted s^low^ly on a da^ily basⁱs _to ach_ieve _the des_ired c_lin_ica_l e_ffec_{t. I}n pa^tien^ts w^ith spas^tic^ity o^f spⁱna^l o^rigⁱn _the da_ily dosage _inc_remen^t shou^ld no^t exceed 10–30

_in pa_tien_ts w_ith spas_tic_ity o_f ce_reb_ra^l o^rigⁱn ^thⁱs shou^ld be ^lim^ited ^to 5–15

W_ith p_rog_rammab_le pumps_{, t}he dose shou^ld be ⁱnc^reased on^ly once eve^r y 24

1 mL so_lu_tion pe^r day^{, i}n^te^r va_ls o^f 48

o_{f r}esponse _to _the dose _inc_remen_{t. If} the da^ily dose has been sⁱgn^ifican^tly _inc_reased and no c_lin_ica_l e_ffec_{t i}s achⁱeved^, check ^fo^r p^rope^r pump ^func^tion and ca_the_te^r pa^tency^.

_In gene_ra_{l i}n pa_tien_ts w_ith spas_tic_ity o^f spⁱna^l o^rigⁱn ^the dose can be ⁱnc^reased _to a ma_in_tenance dose o^f 300 o_rig_in usua_lly _requ_ire lowe^r doses ⁽see be^low^).

• anxiety
• high body temperature
• low blood pressure
• altered mental conditions for example agitation, confusion, hallucinations, abnormal thinking and behaviour, convulsions
• persistent painful erection of the penis (priaprism).

If you have any of the above signs, tell your doctor straight away. These signs may be followed by more serious side effects unless you are treated immediately.

If you use more Baclofen than you should

It is very important that you, and those caring for you, are able to recognise the signs of overdose. These may appear suddenly or slowly for example because the pump is not working properly.

The signs of overdose are

• muscle weakness (too little muscle tone)
• sleepiness
• dizziness or light-headedness
• excessive salivation (hypersalivation)
• nausea or vomiting
• difficulty in breathing (respiratory depression), respiratory arrest (apnoea)
• convulsions
• clouding or loss of consciousness (coma)
• abnormal low body temperature.

If you have any signs of an overdose of Baclofen, tell your doctor straight away.

If you stop using Baclofen

If this medicine must be stopped, this may only be done by your doctor who will reduce the dose gradually to avoid side effects. Suddenly stopping Baclofen can cause withdrawal symptoms which in some cases have proven fatal.

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

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. These occur more often at the start of treatment during your hospital stay, but they may also occur later. Many of these side effects are also known to be associated with the specific medical condition for which you are being treated.

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

• drowsiness
• hypotonia.

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

• decreased appetite
• depression, confusional state, disorientation, agitation, anxiety
• convulsion, lethargy, slurred quiet speech, headache, numbness with tingling of the buttocks and feet, sleeplessness, sedation, dizziness Convulsion and headache occur more frequently in patients with spasticity of cerebral origin than in patients with spasticity of spinal origin.
• accommodation disorders with vision blurred or double vision
• orthostatic hypotension
• respiratory depression, aspiration pneumonia, dyspnoea
• vomiting, constipation, diarrhoea/bowel incontinence, nausea, dry mouth, increased salivation Nausea and vomiting occur more frequently in patients with spasticity of cerebral origin than in patients with spasticity of spinal origin.
• urticaria, pruritus
• hypertonia, muscular weakness
• urinary retention, urinary incontinence Urinary retention occurs more frequently in patients with spasticity of cerebral origin than in patients with spasticity of spinal origin.
• sexual dysfunction (Baclofen may compromise erection and ejaculation. This effect is usually reversible on withdrawal of Baclofen)
• oedema peripheral, face oedema, pain, fever, shivering
• bradypnoea.

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

• dehydration
• suicidal thoughts and attempt, paranoia, hallucinations, feeling of extreme happiness
• impairment of muscle coordination (ataxia), hypothermia, difficulty swallowing (dysphagia), loss of memory / forgetfulness, nystagmus
• bradycardia
• deep vein thrombosis, hypertension, reddening of the skin, pallor
• ileus, reduced taste perception
• alopecia, excessive sweating.

Rare (may affect up to 1 in 1,000 people)

• life-threatening withdrawal symptoms due to drug delivery failure.

Not known (cannot be estimated from available data)

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disturbed mood

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increase in sideways curvature of the spine (scoliosis)

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inability to achieve or maintain an erection (erectile dysfunction).

Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/ yellowcard or search for MHRA Yellow Card in the Google Play or Apple App store. By reporting side effects you can help provide more information on the safety of this medicine.

5.

How to store Baclofen

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

Do not use this medicine after the expiry date which is stated on the ampoule/vial and the folding box. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

The product should be used immediately after opening the ampoule/vial and dilution (in the pump).

Chemical and physical in-use stability has been demonstrated for 6 months at 37°C.

The solution must be clear and colourless. If particulate matter or discolouration are present the solution must not be used and should be discarded.

Any unrequired fraction must be destroyed.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6.

Contents of the pack and other information

What Baclofen contains

• The active substance is baclofen.

Baclofen 10 mg/5 ml solution for infusion:

1 ml solution for infusion contains 2.0 mg baclofen.

Each 5 ml ampoule contains 10 mg baclofen.

Each 5 ml vial contains 10 mg baclofen.

Each 20 ml vial contains 40 mg baclofen

• The other ingredients are: sodium chloride and water for injection.

What Baclofen looks like and contents of the pack

Solution for infusion.

Baclofen is a clear, colourless solution in a clear, colourless ampoule/vial.

Baclofen 10

mg/5 ml, solution for infusion is available in packs containing 1 or 5 ampoules.

Baclofen 10

mg/5 ml, solution for infusion is available in a pack containing 1 or 5 vials.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

The Netherlands

This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Germany:

Baclofen SUN 10 mg/20 ml Infusionslösung

France:

Baclofène SUN 10 mg/20 ml Solution pour perfusion

United Kingdom (Northern Ireland):

Baclofen 10 mg/20 ml Solution for Infusion

Germany:

Baclofen SUN 10 mg/ 5 ml Infusionslösung

France:

Baclofène SUN 10 mg/ 5 ml Solution pour perfusion

United Kingdom (Northern Ireland):

Baclofen 10 mg/ 5 ml Solution for Infusion

This leaflet was last revised in April 2025.

5 2 6 1 5 9 0

M a i n t e n a n c e p h a s e

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W a r n i n g s a n d p r e c a u t i o n s ” ) .

T h e s p e c i f i c c o n c e n t r a t i o n o f b a c l o f e n t h a t s h o u l d b e u s e d t o f i l l t h e p u m p d e p e n d s u p o n t h e t o t a l d a i l y d o s e r e q u i r e d a s w e l l a s t h e d e l i v e r y r a t e o f t h e p u m p . I f b a c l o f e n c o n c e n t r a t i o n s o t h e r t h a n 0 . 0 5

m l a r e r e q u i r e d B a c l o f e n m u s t b e d i l u t e d u n d e r a s e p t i c c o n d i t i o n s w i t h s t e r i l e , p r e s e r v a t i v e -f r e e s o d i u m c h l o r i d e s o l u t i o n f o r i n j e c t i o n s . P l e a s e c o n s u l t t h e m a n u f a c t u r e r ’ s m a n u a l f o r s p e c i f i c r e c o m m e n d a t i o n s .

D u r i n g l o n g -t e r m t r e a t m e n t a p p r o x i m a t e l y 5

i n c r e a s i n g d o s e s b e c a u s e o f l o s s o f e f f e c t ( » d e v e l o p m e n t o f t o l e r a n c e « ) . A s r e p o r t e d i n t h e l i t e r a t u r e a b a c l o f e n -f r e e i n t e r v a l o f 1 0 t o 1 4

i n t r a t h e c a l p r e s e r v a t i v e -f r e e m o r p h i n e s u l p h a t e i s a d m i n i s t e r e d , c a n c o u n t e r a c t t h e » t o l e r a n c e « . A f t e r t h i s i n t e r v a l s e n s i t i v i t y t o t r e a t m e n t w i t h B a c l o f e n m a y b e r e s t o r e d . T r e a t m e n t s s h o u l d b e r e s u m e d a t t h e i n i t i a l c o n t i n u o u s i n f u s i o n d o s e . T h i s s h o u l d b e f o l l o w e d b y a t i t r a t i o n p h a s e t o a v o i d o v e r d o s e a c c i d e n t s . T h i s s h o u l d a l s o b e c a r r i e d o u t u n d e r h o s p i t a l c o n d i t i o n s .

I n c o m p a t i b i l i t i e s

I f r e q u i r e d , B a c l o f e n 1 0

a s e p t i c c o n d i t i o n s w i t h s t e r i l e , p r e s e r v a t i v e -f r e e s o d i u m c h l o r i d e s o l u t i o n f o r i n j e c t i o n ( 0 . 9 % w / v = 9 m g / m l ) o n l y .

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